The Mental Health "Stigma"

Two news items of interest were sent to me over the past few days, both, it would seem, are aligned with one another.

First off, let's take a look out the worn out phrase that lots of mental health specialists and even celebrities seem to trawl out every 5 minutes or so.

The mental health stigma

This from the Mental Health Commission in Australia, I plucked the first one that appeared in a Google search, all mental health foundations say pretty much the same.

Three out of four people with a mental illness report that they have experienced stigma. Stigma is a mark of disgrace that sets a person apart. When a person is labelled by their illness they are seen as part of a stereotyped group. Negative attitudes create prejudice which leads to negative actions and discrimination.

There's not a day goes by when we hear the calls of organizations or celebrities calling for an end to mental health stigma. Canadian writer and actress, Mary Walsh, is one such celebrity.

Walsh is a spokesperson for Bell Let's Talk, an organization that has, according to their website, "Committed over $100 million to support a wide range of mental health organizations, large and small, from coast to coast to coast."

Bell Media is Canada’s premier multimedia company with leading assets in television, radio, out-of-home advertising, and digital media. Bell Media owns 30 local television stations led by CTV, Canada’s number 1 television network.

Today, Today, Bell will donate 5¢ more to mental health initiatives for every:

• Text message sent
• Mobile & long distance call made
• Tweet using #BellLetsTalk
• Share of the Facebook image

That's a very generous offer given that the figure could run into the millions of dollars.

I'm in agreement with them to a certain extent. Yes, we should talk about mental health but the subject matter shouldn't be what more can they do to help depressed people, it should be what harm are they doing to depressed people.

BellLetsTalk, however, seem to back up their stigma claims with some "facts", of which there are many. Here's a few...

In Canada, only 1 out of 5 children who need mental health services receives them. - CMHA

Mood and anxiety disorders impact an estimated 22% of the Canadian population. - CMHA

Suicide accounts for 24% of all deaths among 15-24 year-olds and 16% among 25-44 year-olds. - CMHA

CMHA stands for the Canadian Mental Health Association, their homepage shows one of their principle sponsors to be Lundbeck, manufacturers and marketers of such drugs as Celexa (citalopram) and Lexapro (escitalopram) - which leads me nicely to the second news item that was sent to me this week.

Yesterday the New York Times (NYT) ran a feature regarding an apparent influential government-appointed health panel who have called for women be screened for depression during pregnancy and after giving birth.

Their claims, according to the NYT, "comes in the wake of new evidence that maternal mental illness is more common than previously thought; that many cases of what has been called postpartum depression actually start during pregnancy; and that left untreated, these mood disorders can be detrimental to the well-being of children."

The panel gave its recommendation, which was published in the journal JAMA, a “B” rating, which means depression screening must be covered under the Affordable Care Act.

In the NYT feature a woman/mother is quoted, seemingly to support the call for "maternal mental illness."

Melissa Mead, 30, of The Dalles, Ore, tells the NYT that shortly after her son Brady’s birth, she experienced postpartum depression, anxiety and O.C.D. In her own words she "cried continually, barely slept, rarely left home and was scared to death that my baby was going to suffocate."

Hello!

Isn't this a normal response to giving birth, isn't this just a motherly instinct?

The NYT goes on to say that...

After a year, she saw a psychiatrist for talk therapy. When her second son, Emmett, was born, and she had more symptoms, including fearing that she would stab herself with a kitchen knife, Ms. Mead tried several medications until one worked. She now volunteers for Postpartum Support International.

Several medications until one worked? Are we led to believe that some of them didn't work? Shock, horror, you mean some antidepressants don't work?

Mead is now a volunteer for Postpartum Support International (PSI), an organization whose purpose it is to increase awareness among public and professional communities about the emotional changes that women experience during pregnancy and postpartum.

In 2015 the PSI and Tree of Hope Foundation held their Annual Conference. The conference theme was "Planting seeds of hope: overcoming stigma, increasing options and embracing innovative treatments."

Ah, there's that word - "treatments."

Because the NYT featured a woman's story to support the calls for more screening for women with "maternal mental illness", I thought I'd throw in a story about the kind of treatments used to treat mothers during pregnancy.

Lundbeck's Celexa (citalopram) is one such treatment.

Back in 2013 Scottish mom, Cheryl Buchanan, wrote a guest post for this blog. It was with regard to the birth defects caused to her unborn child. Cheryl aborted her child at 23 weeks after being told that the fetus had severe abnormalities which meant she was incompatible with life.

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl.

Scans had detected a series of anomalies in her unborn child, namely...

• Diaphragmatic hernia or eventration
• Long bone immobility
• Cystic hygroma 
• Unilateral cleft hand
• Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

• (Foetal death in utero) - drug related - possible
• (Pulmonary hypoplasia) - drug related - possible
• (Diaphragmatic hernia) - drug related - possible
• (Hand deformity) - drug related - possible
• (Skin laxity) - drug related - possible
• (Skin swelling) - drug related - possible
• (Drug exposure in utero) - drug related - possible

The actual documents can be viewed here.

Now, I'm sure many people get the cold shoulder treatment when diagnosed (labelled) with a mental illness - but is there really a stigma attached to it?

I'll go out on a limb here and suggest that there is more of a stigma attached to people like Cheryl Buchanan speaking out against the use of antidepressants during pregnancy - people like Cheryl are deemed irresponsible for taking the stance that she has - normally by healthcare professionals and those who wish to believe that antidepressants are safe during pregnancy.

You want facts?

During the citalopram animal reproduction studies it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Meantime, more calls for screening women for mental health illnesses is being touted in the widely read New York Times. If you think the pharmaceutical companies, including Lundbeck, aren't behind this latest push then think again.

Both stories call for more help with the stigma associated with mental illness, of course they do - Big Pharma have something to sell and they want you in their corner helping them push their drugs on unsuspecting mothers.

Bob Fiddaman

Lundbeck: Contradiction in Terms

One of the more popular posts on this blog over the past couple of years has been a guest post by Scottish mom, Cheryl Buchanan. In short, Cheryl aborted her fetus at 23 weeks because she was told that its chances of survival were slim due to several defects.

A series of other posts by Cheryl and myself have appeared on this blog and now, it seems, the mainstream media in the UK have taken an interest. All good, I hear you cry - I guess so, it's good when stories like this are highlighted in the British press but, to be honest, journalism isn't what it used to be. In fact, the article, published on Jan 10 in The Express, leaves more questions than answers, questions that really should have been asked by the reporting journalist, Paula Murray.

Her article highlights Cheryl's plight and also tries to offer balance in the shape of a quote from Lundbeck's Medical Director, Dr. Andrew Jones.

Dr Andrew Jones, Medical Director with Lundbeck, said citalopram should not be prescribed during pregnancy unless "clearly necessary and only after careful consideration of risk/benefit".

However, he said there was "considerable evidence" to show that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child than the potential risks of exposure to the medication".

Dr Jones added: "We are familiar with Ms Buchanan and have supported her with the information she has requested. It is always a tragic situation when one loses a child. We will not comment on her personal case in public but the safety of Lundbeck’s antidepressants is supported with the large amount of data that has shown no evidence of an increased risk of birth defects associated with treating pregnant women with citalopram."

I left a comment on the Express article suggesting that Jones was having his cake and eating it, sadly, for some bizarre reason, that comment has been removed. Kind of weird given that the journalist in question was given the links to Cheryl's story that have appeared on my blog over the past couple of years.

Why didn't the journalist ask Dr. Jones for the  "considerable evidence" that shows that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with greater risks to the woman and her unborn child than the potential risks of exposure to the medication?

Why didn't the journalist ask Dr Jones about the citalopram animal reproduction studies where it was shown that citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects resulting in in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) (Source FDA)

Furthermore, why wasn't Jones pushed for an answer in defining the terminology, Possibly, Probably or Certain? There's a whole new can of worms there for anyone seeking that Pulitzer.

Contrast the citalopram animal reproduction studies with the claim of Dr Jones that women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child - it's a theory folks, one that has been blown out of the water many times by other academics. The citalopram animal reproduction studies is the actual science here and really should have been picked up by the reporting journalist.

Dr Jones is towing the company line, ie; he's keeping lawyers at bay and expectant mothers at risk - throwing in the line, "citalopram should not be prescribed during pregnancy unless clearly necessary and only after careful consideration of risk/benefit", is nothing more than a mandatory disclaimer used by pharmaceutical companies, they know their drugs are being used in pregnancy yet they just sit back and allow it to happen because they believe the prescribing physician is in a better position to judge whether or not the patient will benefit from the drug. Lines such as " women who stop taking antidepressants during pregnancy are more likely to suffer a recurrence with "greater risks to the woman and her unborn child", will always persuade prescribing physicians that antidepressant drugs are a must for depressed mothers - even though this statement is merely a theory.

Begs the question why Jones failed to mention the citalopram animal reproduction studies to the investigating journalist.

Meantime, Cheryl Buchanan remains in limbo and her child, through no fault of her own, remains dead.




Bob Fiddaman.

Back Stories

Citalopram Birth Defects (Guest Post)

Are Lundbeck Luring Pregnant Mothers With a Red Apple?

Lundbeck: Possibly, Probably or Certain about Celexa Birth Defects?

MHRA: Double Standards

I first became aware of the British drug regulator, the MHRA, adding a copyright notice to Freedom of Information request responses some time ago.

They first did this to me in 2007. I had sent them a series of questions regarding the suicide link in GlaxoSmithKline's antidepressant Seroxat (known as Paxil in the US)

The copyright notice reads...

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder. 

I, as you would expect, took umbrage to this and let my feelings known via this blog (here)

Again, this time in 2014, the MHRA, once again saw fit to include a copyright notice to another response to a Freedom of Information request I had sent them. This was in response to an FOI request I had sent them regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury) Back story here.

Earlier this week I was contacted by Cheryl Buchanan who has, in the past, wrote a guest post for this blog. (here) Cheryl had requested an answer from the MHRA (under the terms of the FOIA) regarding SSRi use in pregnancy. It's important to note that Cheryl has been at loggerheads with the MHRA and citalopram manufacturers, Lundbeck, for some considerable time now.

The MHRA sent Cheryl a response and included a copyright notice. Cheryl wrote back the following to them.

Dear MHRA,

Thank you for responding to my request, I have some further questions which I will sent to you shortly but at the moment I am perplexed as to why you have put a copyright on the response you sent me?  I feel it is within pubic interest to have the data within the response available to anyone who would like to see it. Is every paragraph copyrighted or am I allowed to share any of the information which relates to myself and my own report?

The response from the MHRA was...

Copyright information is included in responses from the agency where data is presented to the requestor. Data given in these types responses has the potential to be taken out of context, and the agency would wish anyone who has requested information from us to include the context when sharing information.

The agency is happy for you to share information released under the Freedom Of Information Act, indeed from the agencies perspective the response is already deemed as being “in the public domain”. The copyright notice is included as the information should be able to be traced back to the MHRA as the source, and as mentioned previously, the context can be included.

So now I'm confused?

You see, when a pharmaceutical company apply for a licence for one of their drugs they are supposed to submit supporting evidence. They do this by cherry-picking the best results from clinical trials. The poor results (ie; those showing that efficacy has not been proven) are never sent to the MHRA.

Here's my take on the MHRA copyright notice.

Would it be fair to say that when pharmaceutical companies submit clinical trial results to the MHRA in support of drug licensing that they include the failed clinical trials...so the actual benefit of a drug isn't "taken out of context"?

Just a thought.

What's good for the goose is good for the gander, right?


Bob Fiddaman.

Lundbeck: Possibly, Probably or Certain about Celexa Birth Defects?

Possible or probable, so what is the difference?

I've struggled with these two definitions, really tried to get my head around them both.

First off I used Dictionary.com

Possible:
1. that may or can be, exist, happen, be done, be used, etc
2. that may be true or may be the case, as something concerning which one has no knowledge to the contrary

Probable:
1. likely to occur or prove true
2. having more evidence for than against, or evidence that inclines the mind to belief but leaves some room for doubt.
3. affording ground for belief.

When it comes to prescription medications causing adverse events, the World Health Organisation (WHO) use "causality categories" and define possible and probable as thus...

Possible:
• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Could also be explained by disease or other drugs
• Information on drug withdrawal may be lacking or unclear

Probable:
• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Unlikely to be attributed to disease or other drugs
• Response to withdrawal clinically reasonable
• Rechallenge not required

In essence both words have two possible outcomes yet both have different meanings.

I am going to focus on the case of Cheryl Buchanan here and her correspondence with citalopram makers Lundbeck. Citalopram is better known as Cipramil in the UK and Celexa in the US. ( Forest Laboratories)

Cheryl has been at loggerheads with Lundbeck regarding the death of her baby girl. Cheryl made the heart wrenching decision to abort her fetus at 23 weeks because she had been told that scans had detected a series of anomalies in her unborn child, namely...

• Diaphragmatic hernia or eventration
• Long bone immobility
• Cystic hygroma 
• Unilateral cleft hand
• Microgynathia

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

Lundbeck carried out an assessment of Cheryl's claims and forwarded their findings to the MHRA.

Lundbeck, as far as I am aware, also use the World Health Organisation "causality categories".

Here's what they found.

(Foetal death in utero) - drug related - possible
(Pulmonary hypoplasia) - drug related - possible
(Diaphragmatic hernia) - drug related - possible
(Hand deformity) - drug related - possible
(Skin laxity) - drug related - possible
(Skin swelling) - drug related - possible
(Drug exposure in utero) - drug related - possible

Fig 1.

Fig 2. **Initial reporting from Lundbeck to the MHRA did not give any indication for Cheryl's fetus developing Pulmonary hypoplasia**

Fig 3. **Updated assessment by Lundbeck sent to the MHRA regarding a possible connection between citalopram related Pulmonary hypoplasia**

Sometime later Cheryl wrote to Lundbeck and asked if citalopram could cause birth defects?

Here's the reply from Lundbeck's Dr Andrew Jones, Medical Director, Medical Department.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " 

It was at this point that I wrote to Dr Jones to ask him if this was a personal opinion or an opinion of Lundbeck. He replied...

Dear Mr Fiddaman,

I confirm that this is the position of Lundbeck.

What I am struggling with here takes me back to the definitions of possible and probable.

Lundbeck assess Cheryl's case and write to the MHRA with their findings. They tell the MHRA that the birth defects (listed above) are possibly drug related. Using the WHO criteria this means that...

The defects could just be coincidental to Cheryl's "drug intake" or

The defects may possibly have been caused by "disease or other drugs" or

The Information Cheryl provided Lundbeck "may be lacking or unclear" 

Let's now take a look at the position of Lundbeck regarding citalopram use and birth defects. Remember, it was their own Dr Jones that told me that the following was the position of Lundbeck...

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " 

So, how do we categorize the position of Lundbeck. Are they suggesting that it's possible that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Are they saying it's probable that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Or are they saying they are certain that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Back to the WHO criteria again.

Certain:
• Event or laboratory test abnormality, with plausible time relationship to drug intake
• Cannot be explained by disease or other drugs
• Response to withdrawal plausible (pharmacologically, pathologically)
• Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon)
• Rechallenge satisfactory, if necessary


Lundbeck have done nothing more than open the door for debate when sending information back to the MHRA.

Where the mother is concerned they have quite literally slammed the door on her face by telling her that their position is there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population.

Why would they (technically) tell the MHRA otherwise?

Why would Lundbeck tell the MHRA that it was possible that citalopram caused the birth defects in a mother's fetus but tell that same mother something completely different?

I'm confused by it all. Is the WHO criteria merely a set of probabilities with at least two possible outcomes? If so, it doesn't really tell us much does it?

Is the WHO criteria not as stringent as they think and each category open for debate?

What we basically have is two opposing statements of reality intertwined.

The third statement of 'certainty' by Lundbeck to Cheryl Buchannan being an ultimatum, in essence, "our drug does not cause birth defects", forgetting or purposely failing to add that they told the MHRA otherwise.

It's certain that Cheryl Buchanan aborted her fetus at the age of 23 weeks because, she was told, the chances of survival were minimal due to a series of internal defects.

My money is on citalopram being the cause of those defects.

Any good lawyers in the UK?

Bob Fiddaman.

Back Stories

Citalopram Birth Defects (Guest Post)

Are Lundbeck Luring Pregnant Mothers With a Red Apple?

Are Lundbeck Luring Pregnant Mothers With a Red Apple?

After turning into the Witch, the Queen declares that Snow White should suffer "a special sort of death". Looking through her spell book, she comes to the recipe for the Sleeping Death, and, reading of the Poisoned Apple's effects, decides that it's the perfect way to get rid of the princess. She brews the potion and dips an ordinary apple into the brew as the Raven watches silently. The Sleeping Death seeps into the apple, and the Witch raises the apple from the cauldron to reveal that the poison dripping from the apple has formed an image of a skull. This image fades as the apple turns red, to tempt Snow White. - Disney Wiki

I'm confused.

Can citalopram, marketed and manufactured by Lundbeck in Europe, cause birth defects?

It's a simple enough question that should be simple enough to answer. It is, when all's said and done, a very important decision to make for any pregnant mom who may be faced with a choice of taking or not taking citalopram during pregnancy.

Sadly for Scottish mom Cheryl Buchanan this is not an option.

When Cheryl was just 12 weeks pregnant she was told that scans had detected a series of anomalies in her unborn child.

• Diaphragmatic hernia or eventration
• Long bone immobility
• Cystic hygroma 
• Unilateral cleft hand
• Microgynathia

A post-mortem revealed that Cheryl's unborn child that half of her daughter's diaphragm was absent, her lungs were very small, some of her organs had moved up into the thoracic region,  her neck had webbing, and her nose was small while her chin was recessed.

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

What follows is bizarre to say the least.

Cheryl wrote me and asked me to read through a collection of emails sent to her by Lundbeck. I asked for Cheryl's permission to contact Lundbeck directly - she agreed.

Cheryl had previously asked Lundbeck if citalopram could cause birth defects. Their answer, in a nutshell, was that here was no evidence of this.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " - Dr Andrew Jones, Medical Director, Medical Department, Lundbeck

I wrote directly to Dr Jones...

Dear Dr Jones,

I have seen the attached correspondence you wrote and sent to Cheryl Buchanan regarding citalopram and birth defects.

I understand that you will not be able to discuss with me individual cases but I feel I must press you for some clarification.

You wrote, " "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). "

Can you clarify if this is just a personal opinion or if it is the position of Lundbeck.

Initially Dr Jones did not respond so I told him I would make the question to him public. Strangely Lundbeck then checked me out [Fig 1].

Fig 1

Dr Jones replied shortly after Lundbeck had paid a visit to my blog, his reply to me was short...

Dear Mr Fiddaman,

I confirm that this is the position of Lundbeck.

 I wrote the following back to Dr Jones...

Dear Dr Jones,

Many thanks for your reply, although it has to be said that Lundbeck are misleading Ms Buchanan with their rather ambiguous statement regarding the risks of taking citalopram during pregnancy.

As you are probably aware the pregnancy risk with citalopram is classed as a 'Category C', ergo risk cannot be ruled out. To suggest otherwise to a woman of child bearing age is irresponsible and misleading.

Do you or, indeed, Lundbeck, wish to amend your response to Ms Buchanan or do you wish to stand by your position that citalopram does not cause birth defects?

Whilst waiting for a response I fired off an email to Sandy Walsh, Sandy is a press officer at the FDA, more specifically for the Center for Drug Evaluation and Research. I also sent a reminder to Dr Jones that if he did not answer my follow-up question I would make it public on my blog.

Here's the email I sent the FDA...

Dear Sandy,

I'm very confused.

Recently a reader of my blog contacted me regarding the antidepressant citalopram, marketed in Europe by Lundbeck.

She had to abort her fetus due to it developing birth defects inside the womb.

Whilst I am aware that you cannot discuss individual cases with me I'd like to bring to your attention an email that the woman received from Lundbeck.

She asked if citalopram could cause birth defects.

The answer, from Dr Andrew Jones Medical Director, Lundbeck UK, was "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population."

My question to you may clear matters. Could you tell me why the FDA have assigned citalopram to pregnancy category C and whether or not Lundbeck/Forest had any input in arriving at that decision?

Hopefully your answer may clear this confusion up.

Sandy Walsh was very helpful with her response, I've highlighted the relevant parts...

Here is the FDA-approved prescribing information (labeling) for Celexa: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf

As noted on page 18, there is a description of why Celexa is category C:   

-----

Pregnancy Category C : 

In animal reproduction studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human therapeutic doses. In two rat embryo/fetal development studies, oral administration of citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose, which is approximately 18 times the MRHD of 60 mg/day on a body surface area (mg/m2) basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental, no-effect dose of 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. In a rabbit study, no adverse effects on embryo/fetal development were observed at doses of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis. Thus, teratogenic effects were observed at a maternally toxic dose in the rat and were not observed in the rabbit.

When female rats were treated with citalopram(4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were observed at the highest dose, which is approximately 5 times the MRHD on a mg/m2 basis. The no-effect dose of 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥24 mg/kg/day, approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study. There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus.

-----

Category C means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. The pregnancy categories are assigned based on current scientific evidence and can be changed if new information is learned.

The company and the FDA both work together to add drug benefit/risk/safety information into the drug labeling.  So yes, the company plays a role in what is contained in the drug labeling.

The pregnancy categories

If a person has an adverse event, that should be reported by the doctor or patient to the FDA (or European authority), or the drug company, so that it can be properly logged into the official adverse event tracking systems.

I wrote the following back to Sandy Walsh...

Sandy,

Thank you for this.

I have found your help in this, and other matters where I have contacted you before, very helpful.

Can you explain why Lundbeck would be telling consumers/patients that there is no risk during pregnancy?

I can forward you the letter if you wish?

Sandy's response was...

I cannot speak for the company, please ask them.

As noted, the US drug labeling says, "There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus."

Not very satisfying so I pushed Sandy for something more definitive...

The company are, at this moment in time, refusing to answer any further questions from me.

This is potentially dangerous and misleading information they are handing out to women of child-bearing years.

If the company won't give me an answer and the FDA cannot speak about Lundbeck's stance then who can I ask?

Do you have a procedure whereby I can ask the FDA to ask on my behalf?

It's a strange way to safeguard human health, don't you think?

Here's Sandy's response...

Apologies, I have a number of other things I’m working on and meetings today.

The FDA is only able to provide the information I’ve given to you – the warnings in the FDA-approved drug labeling   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf.

If someone believes they’ve experienced an adverse event, they should contact the drug authority in that country. 

In the U.S., if there is adverse event information to submit, it should be submitted to our MedWatch system along with medical information from the physician, and the information from the company. Here are instructions as to how to do that: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm

In other words, sorry you are on your own.

Here we have a pharmaceutical company handing out information to a woman that claims that there is no link between citalopram use and birth defects. The American drug regulator, the FDA, inform me that during animal studies there was an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects)

They add that there are no adequate and well-controlled studies in humans and that  potential benefits may warrant use of the drug in pregnant women despite potential risks.

This is baffling?

If no adequate and well-controlled studies in humans has been carried out [and they never will be because it would be unethical to use a human fetus as a guinea pig] then how can they suggest that there is a chance of "potential benefits"?

If no adequate and well-controlled studies in humans has been carried out then why are doctor's prescribing citalopram to women who are pregnant? There is no gauge here so women just have to trust their healthcare professionals who are prescribing a drug blindly. Who informed the doctor's about the potential benefits of non-existent adequate and well-controlled studies?

How did we get to the stage where a drug that has never been through clinical testing for pregnant humans is now being prescribed on the premise that the benefits may outweigh the risks? What benefits?

You can't claim that a drug has benefits and that they must be weighed against the risk when you cannot even show clinical trials that highlight those benefits.

Bizarre.

This really is a game of Russian Roulette, right?

These findings are even more startling when you consider that Cheryl Buchanan is just one mom, how many more women of child bearing years have been told by Lundbeck that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Contrast Lundbeck's dismissal of citalopram being linked to birth defects with a 2006 warning regarding Citalopram and birth defects issued by the FDA.

Dr Andrew Jones, Medical Director, Medical Department, Lundbeck has not responded to further questions from me. If he does respond at a later date I will update this post.

Citaloptram is better known by the brand name of Cipramil in the UK and Celexa in the US.

It could be argued that it's akin to the red apple used to lure Snow White.



Bob Fiddaman

If you, or someone you know, has taken citalopram and has had birth defect issues then you may be liable to file a lawsuit [US ONLY] - HERE.

GUEST POST - The Lundbeck Runaround

The following is a guest post from Cheryl Buchanan. Cheryl has previously written a guest post on this blog [link at bottom] - this is an update regarding her mission to seek the truth from Lundbeck, a Danish pharmaceutical company who manufacture the antidepressant citalopram, known by its brand name of Cipramil and known in the US as Celexa.

It's worthy to note that both citalopram and its sister drug, escitalopram, are both the subject of litigation in the United States. For further information please visit Forest Illegally Promoting Antidepressants for Kids!


GUEST POST - The Lundbeck Runaround

Back in December Bob Fiddaman very kindly invited me to write a guest post for his blob. I had contacted him after finding his blog while scouring the Internet for information about anti depressants and birth defects. I had just discovered that before, and during, the time of my first pregnancy in 2004 I had been prescribed the SSRI antidepressant citalopram. My daughter was born at 23 weeks gestation, she had multiple abnormalities and was incompatible with life.

Upon speaking to Bob I sadly discovered I was not alone and that there have been many women whose children developed birth defects in pregnancy while their mothers were taking citalopram and other SSRIs.

At the time I was assured it was safe and was wholeheartedly encouraged to keep taking it. I was on a very high dose (60mg) which is no longer prescribed as its known to cause long QT syndrome in adults.

It has now also been proven that it can cause birth defects, especially those related to the heart and abdominal wall. My daughter had no diaphragm and other abnormalities, all of the details are included in my previous guest post 

I have been in contact with Lundbeck to ask them a series of questions, in the beginning they were more that happy to accommodate, every email was replied to promptly. That was until the chat I had with Bob where we decided it was a good idea to copy Bob in on all the correspondence between myself and Lundbeck. It appears Lundbeck did not like this.

The first email I sent, with Bob cc'd, went unanswered. I waited a good few weeks but still nothing, I gave them the benefit of doubt and emailed again just in case they hadn't received it but yet again, no reply. Bob also told me that he had noticed an IP address he did not recognize had visited his blog, he decided to trace the IP and yep, you've guessed, it was Lundbeck in Copenhagen. By now I was getting majorly pissed. I decided to call Lundbeck and ask why they hadn't answered. This is the conversation that followed.

Conversation with Lundbeck employee 1.30pm 22/07/14

(CB - me, LU - Lundbeck)

CB - Hi can I speak to Ms Warrilow please?

LU - I'm sorry but she is not in today, it is anything I could help you with?

CB - Maybe you could but I'll have to explain the situation I'm in first.

LU - OK, go ahead.

CB - Back in 2004 I had a baby who developed severe abnormalities, she was incompatible with life and passed away at 23 weeks gestation. I was prescribed Citalopram at a dose of 60mg prior to, and during pregnancy. My GP knew I was trying to conceive and prescribed folic acid to me.

I was also told by more than one GP at my surgery that SSRI antidepressants were safe. I have a fair feeling citalopram caused my daughters birth defects. I had been in correspondence with Ms Warrilow who was answering some questions I had. We were in contact for several weeks but I have not had a reply to the last email I sent with a question, this was in December, or any subsequent emails asking why I was not being replied to.

LU - Oh, that's strange, maybe the question you had didn't have an answer. Why do you seem to think citalopram caused the birth defects, that's not a question there is an answer to, that's like asking if the sky is blue.

CB - I want to know because I am her mother and at the time no cause was found for her problems, she had normal chromosomes. I know from researching that SSRI's can cause birth defects.

LU - We recommend that the patient speaks to their GP, that is our guidance.

CB - I am way beyond "Speaking to my GP", I have had a meeting with the Clinical Director of the maternity hospital my daughter was born in, its in my records that he sent a yellow card warning to the Centre for Adverse Reactions in Scotland about the adverse reaction to Citalopram.

LU - When was this again, 2004, Oh I don't know if you will get any information, it was a long time ago.

CB - I have contacted the MHRA as my consultant contacted them. I wanted to ask if they had any information.

LU - The MHRA won't have any information, all reports are anonymous. I don't understand why you want to know, there is nothing that can give you a definitive yes or no.

CB - Would I be better contacting Lundbeck in Denmark directly? Or is there someone else I could speak to?

LU - Why would you want to do that, Eve already told you, we recommend you go back and see your GP.

CB - So all of this is my GP's fault for prescribing it?

LU - We tell the GP's to read the PIL, and the information we give them, and make their recommendations from that.

CB - But did the PIL or your information for GP's state the risk of birth defects in babies back in 2004?

LU - Oh we never recommend prescribing antidepressants in pregnancy, no studies have been done.

CB - There are other SSRI's, paroxetine being one, which is known to cause birth defects, I know citalopram is a category C, paroxetine is D.

LU - Oh, but we still do not recommend it in pregnancy.

CB - When will Ms Warrilow  be back?

LU - Tomorrow, what is your name and I will get her to contact you?

CB - Cheryl Buchanan, I have emailed a couple of times and had no reply.

LU - It must be the spam filter, we have been very busy and maybe just haven't gotten to your emails.

CB - It is possible its because I have copied Mr. Bob Fiddaman in on the correspondence? He has been giving me help and advice and has a lot of knowledge about SSRI's. He also has a blog and told me his blog has been visited a number of times by an IP he did not recognize, after checking it he found it belongs  to Lundbeck in Denmark so I think that you have been receiving my emails.

LU - I don't know anything about it. I will have Ms Warrilow contact you. Are you still taking Citalopram?

CB - No.

LU - Are you on a different SSRI?

CB - Yes but I am withdrawing from using it as I will not be a hypocrite and take something which more than likely killed my daughter.

LU - Are you doing this under GP's guidance.

CB - Yes. Thanks you for your time. Goodbye.

LU - No problem, bye.

I was dumbfounded. I awaited a response but once again was ignored. So I waited some more, just long enough for them to think I had gone away.

Then I called their head office again, this time the person who answered the phone was the one who I'd been speaking with by email.

Conversation with Ms W (Lundbeck) 17/02/14 - 4.30pm

CB - Hi can I speak to Ms Warrilow please?

LU - This is her speaking...

C - Hi, I am not sure if you know who I am but my name is Cheryl Buchanan, I was speaking to you through email a couple of months ago, about my daughters birth defects?

LU - Yes, I do remember

CB - I sent you an email back in December and I never got a response, I have since then emailed you several times and never got a reply.

LU - Oh, er, I think that was because there wasn't really anything else we could say to you.

CB - I understand that but it would have been more courteous if you could have replied telling me that, this situation is consuming my life at the moment and having to send repeated emails, with no answer, it doesn't help.

LU - Oh, yes, I do apologize.

CB - I actually called a couple of weeks ago and spoke to a colleague of yours, she took my details and assured me she would have you contact me.

LU - Oh, erm...

CB - I hope you understand I'm not blaming you personally, I know its absolutely nothing to do with you but a reply would have been helpful, even if to say you didn't have anything else to tell me.

LU - (Silence)

LU - The MHRA have been in touch with us, you asked in your email if they contacted us in 04, they didn't but have since, they might be able to help you. Would you like a copy of the information they sent us? It is anonymous but we figured it was you.

CB - I filled in another yellow card a couple of months ago and asked for them to contact me, I never got a reply, I imagine they have contacted you about the Yellow card I sent recently. If you could send me a copy of what they sent you I would really appreciate it.

LU - OK, that's not a problem.

CB - Can I ask a question? Do you know what the PIL stated about prescribing citalopram in pregnancy back in 2004, or could you find out? What I'm trying to figure out is if GP's would have known citalopram was a teratogen back then?

LU - I can get a copy of it, I'm sure it said use with caution but I can find out for you and send a copy of the 04 PIL to you.

CB - Do you know when the risks of prescribing in pregnancy were was added to the PIL, was it 2004?

LU - I'm not sure, the PIL changes all the time.

CB - I'm trying to figure out if GP's would have known Citalopram was a teratogen.

LU - I can get you a copy of the GP information and send it to you? I'm sure it would have said use with caution in pregnancy.

CB - That would be great

LU - Do we have your address, I don't think we do?

CB - No you wouldn't have, all our conversations were by email. (I give her my address)

LU - I will get that sent to you tomorrow, do you remember us sending you a permission form for you to sign so we can contact your GP?

CB - Yes but I don't have a printer so can't return it, could you send me a paper copy please?

LU - Of course, Ill get it send out to you along with the other information.

CB - Thank you for your time, bye.

LU - Bye.

While I had been awaiting a reply I decided to complain to the MHRA about Lundbeck's lack of response, just today they sent me a reply which seems to have been written by a robot and in no way at all answers the complaint I put to them.

Dear Ms Buchanan,

Thank you for your email regarding the lack of response from Lundbeck and your concerns regarding the product Citalopram. We are very sorry to hear about what has happened to you and your daughter.

Your email was treated as a patient report and we were as a consequence able to link this up with your previous correspondence with the Vigilance and Risk Management of Medicines Division.

In relation to Lundbeck your information has been passed to the Inspection, Enforcement and Standards Division who have responsibility for conducting Pharmacovigilance inspections of Marketing Authorization Holders (MAHs) such as Lundbeck. This information will be entered into the risk information system; this system is used to determine how often organizations are inspected. At such inspections we check how the MAH handles reports such as your own as they have responsibility for the on-going safety of products on the market. During any such inspection we do of course preserve the identity of any individuals such as yourself.

Once again, thank you for alerting us to this potential adverse reaction and the actions of the company.

Kind Regards,

Customer Services External Relations Medicines and Healthcare Products Regulatory Agency

Right now I am furious. This morning on my daily hunt of the net for info I was on Lundbeck's LinkedIn page. In the careers section their is a large photo header with the statement "Everyone deserves quality of life". How completley and utterly hypocritical. What about my daughters "quality of life"?

Because of a medication, made by them, which they knew in studies killed of the fetuses of pregnant rats and they marketed as being safe in pregnancy, my daughter is dead. She never got a chance of life. So Lundbeck, if you are reading this, please know that I'm not going to go away. I will keep doing my utmost to prove your are responsible for my child's and hundreds, possibly thousands, of other children's birth defects.

I have had several women come to me in the past few of weeks to tell me their story and how their children were born with birth defects after taking SSRI medication. I am not only doing this for my child, but for all the children whose lives have been damaged by your drugs.

To Bob Fiddaman, thank you from the bottom of my heart.


Back Stories

Citalopram Birth Defects (Guest Post)

The Lundbeck Emails [Citalopram Birth Defects]

The Lundbeck Emails [Citalopram Birth Defects]

Two weeks ago Cheryl Buchanan wrote a guest post for this blog entitled 'Citalopram Birth Defects'.

Cheryl told how, after just 12 weeks, she was informed that the child she was carrying had a series of anomalies. Cheryl wrote:

The most severe of which included suspected diaphragmatic hernia or eventration, long bone immobility (I had never felt her move but as this was my first pregnancy I didn't know, I had nothing to compare it to), a cystic hygroma, unilateral cleft hand and microgynathia. I was also told that she might have brain damage which would explain the fact she didn't (or possibly couldn't) move.

Lundbeck are the manufacturers of citalopram, also known by its brand names Cipramil and Celexa, and Cheryl felt compelled to write to them for answers. Who can blame her?

I'm publishing Cheryl's emails with her permission. I don't need permission to publish Lundbeck's responses.



Nov 4 - Cheryl to Lundbeck

Dear Sir or Madam,

I am contacting you regarding the death of my daughter in 2004. I was taking citalopram at 60mg and became pregnant, I was told to continue the citalopram (it's physically written in my medical records) and as such my daughter whom I was pregnant with developed major abnormalities which meant she was incompatible with life. She died at 23 weeks gestation as I had to have a feticide procedure and induced Labour. I have recently come to believe upon gaining access to my medical records that citalopram was to blame and I have several questions I would like to ask your company. If someone could reply to me I would be very grateful, I plan on acquiring as much information as possible and have done a lot of research and spoken to other people who's families have been affected by citalopram. I have also spoken with some journalists who, if I give consent, plan on publicising my case in the newspapers in Scotland. I hope lundbeck are going to take my questions and claim that your drug was to blame very seriously. My daughter is dead because of this and I will not stop until I get the answers I deserve.

Cheryl Buchanan
File(s) attached

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Nov 5 - Lundbeck to Cheryl

From: UKInfo@Lundbeck.com
To: REDACTED
Date: Tue, 5 Nov 2013 18:04:37 +0100
Subject: FW: Email sent from Lundbeck.com

Dear Ms Buchanan

I am just following up concerning your recent email to us on.  You mentioned that you had a number of questions you'd like us to respond to, however, as yet we haven't had an email from you with the questions on, and I was just wondering if this had gone astray on its way to us?  If you send any future emails or request to our Medical Information mailbox in the UK (ukmedicalinformation@lundbeck.com) we will be happy to address the points that you needed information on.

We can understand your reluctance for us to write to your doctor at this time.  However, I wonder if we could ask for one small piece of information?  In your email to us at the end of last week, you mentioned that when you obtained your records your doctor had reported the case to the MHRA.  Would you happen to have a case reference number for this that would be possible to let us know at all?  As mentioned in my email of last week, we do treat any report of unwanted effects seriously and have a obligation to also follow them up and obtain as much information as possible.

With kind regards

Medical Information Manager

Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

Nov 8 - Cheryl to Lundbeck

From: REDACTED
Sent: Friday, November 08, 2013 3:10 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck, these are the questions I would like answered with regards to my daughters death while taking Citalopram.

1. Were Lundbeck contacted by the MHRA after being sent the Yellow Warning card by my consultant at the Princess Royal Maternity hospital in 2004?

2. What is the process when an adverse reaction of this nature is reported to Lundbeck?

3. Do Lundbeck ever follow up these reports and, or, contact the patient involved?

4. In the time leading up to 2004 (the year of my daughters death) there were 16 adverse reactions reported for congenital and familial /genetic disorders.

By September 2013 according to the D.A.P. for Citalopram the reported side effects of congenital disorders had risen to 82. 5 of these cases were stated as "fatal".

Also in the "pregnancy" section of the report 6 fatalities implicating citalopram were also recorded. So, according to the information stated in the D.A.P. Citalopram was an indicated factor in the death of 11 babies. One of which being my daughter. Very sadly, I also read that there were 20 "spontaneous abortions", four premature birth ands 2 still births. So that brings the total to 13. This is only the totals of cases which have been reported through the yellow card system to the MHRA, what about the cases that do not get reported, for instance if the woman was only on citalopram in early pregnancy, for example up to 4 - 6 weeks, finds out she is pregnant, stops this drug but subsequently in later pregnancy finds there is fetal abnormalities or that their baby has passed away. Do you have any idea, on average, of what percentage of suspected adverse affects are reported by the primary caregiver of the woman? There must be many cases where the medication was stopped very early on and then if abnormalities are found the drug citalopram is not indicated as it was stopped earlier in the pregnancy or, even if it was suspected, it was not reported to the MHRA. I understand it is not compulsory.

5. Has Lundbeck recently done, or plans to carry out, any studies into the iatrogenic affects of their medication?

6. If Lundbeck believe that citalopram does not cause birth defects then why have warnings been been introduced into the P.I.L.?

"When taken in pregnancy, particularly in the last 3 months of pregnancy, medicines LIKE citalopram may increase the risk of a serious condition in babies, called Persistent Pulmonary Hypertension."

PPHN is classed as a birth defect or congenital abnormality. My daughter suffered from Pulmonary Hypoplasia due to Diaphragmatic Hernia. This is closely associated with PPHN.
 
According to the website ChildrensColarado.org
       
"PPHN sometimes develops as the result of another event during delivery or from a disease or congenital condition affecting the newborn (usually one that either directly affects the lungs or oxygen supply to the baby before or after birth)."
       
"Certain congenital conditions that result in immature or incomplete lung development (such as diaphragmatic hernia) may also be associated with PPHN."
 
So basically, you could say by theory of logic, my daughter had no diaphragm and her lungs were less than a third of the size they should have been for her gestation, this would have more than likely caused PPHN, which is stated on your P.I.L. as being an "adverse reaction" to your medication Citalopram. So not only did your medication cause my daughter not  to develop normally, (which isn't really suspiring considering I was told to stay on it and at a dose of 60mg which is horrendous to think about), it would have contributed to my daughters demise had she been born alive. Neither myself or my partner have any history in our families of miscarriage, still birth or congenital (or hereditary) abnormalities or syndromes. As my daughters Karotype was normal this rules out tow of the three main factors. The last one is environmental which would include subjecting the much loved and wanted fetus, growling in my tummy, to a horrific amount of serotonin, an amount which has been proven to be unsafe in fully grown adults. Do you have an explanation for this and why it was deemed to be safe for a pregnant woman when it is not prescribed to adults at this dose anymore? I was not informed of any side effects of this drug by anyone, at any point in my care, I was told it was safe by numerous healthcare professionals.

7.  I have read a lot about the "benefit outweighing the risk". I don't see how a mother, whoso depression has been under control for a long time, she is happy and looking forward to the birth of her newborn, can benefit by being prescribed a drug, which then goes on to cause major abnormalities, weeks of tests, scans and hospital visits, all the while being absolutely devastated and clinging on to every hope her child would be OK and spending every night forcing herself to stay awake as she was so scared her baby would die, talking and singing to her baby, telling her baby how much she loved them and how sorry she was that she could not protect her baby, Contacting specialists in hospitals all over the UK to finally have to death with the death of her child and go through induced labor knowing that her child is dead, and then to see all of the malformations her beautiful angel had, and to have to live with the loss and huge hole in her heart every second of every day, blaming herself, torturing herself with guilt... What benefit did citalproam give this mother. I know the answer. None, that mother is me. This drug destroyed my daughters life and left an irreplaceable whole in my heart which will never heal until I join my daughter in heaven. So please, tell me again, what was the benefit?
   
I would be very grateful if you could answer my questions as honestly as possible, but to be honest I don't hold out much hope. I just want you to understand the "adverse reaction" your drug has had on my life.
   
I have lived with this "adverse reaction" every day for the past nine and a half years and will continue to live with it till the day I die.

Cheryl Buchanan

----

Nov 8 - Lundbeck to Cheryl

-----Original Message-----

From: UK Medical Information
Sent: 8 Nov 2013 16:58:05 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

A quick note to confirm that I have received your questions this afternoon. I have forwarded these on to our global safety team at our headquarters in Copenhagen, and we will give these our full attention and should be able to get back to you with a response, early next week.

With kind regards

Karen Warrillow

----

Nov 13 - Cheryl to Lundbeck

From: REDACTED
Sent: Wednesday, November 13, 2013 5:24 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck,

I am writing to ask if there has been any response from your safety team in Copenhagen yet? The reason I ask is you had stated in your last email to me that I would receive a reply early this week, tomorrow is Thursday and I am very anxious for a reply. I have been speaking with the MHRA and UKTIS and I am awaiting a response from them too. If it is going to take longer than first anticipated that is not a problem but either way if you could let me know what's happening I would really appreciate it, thank you.

Cheryl Buchanan

----

Nov 14 - Lundbeck to Cheryl

From: UK Medical Information
Sent: 14 Nov 2013 09:47:06 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

I apologise that I have not been able to be in touch as I had hoped, earlier in the week.  I am still awaiting for some information from our global team and also from the MHRA in order for us to be able to fully answer your questions.  I would hope that I should receive this information later today, so I can put the information together and send a response to you tomorrow.

Karen Warrillow
Medical Information Manager

Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

18 Nov - Cheryl to Lundbeck

From: REDACTED
Sent: Monday, November 18, 2013 12:21 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck,

I am writing to ask if there has been any progress on your reply to me regarding the questions I had sent you? I don't like to keep bothering you but I was told I would have had a reply by early last week. I know you were waiting on information and was wondering if you received it yet? If not that's fine but I am suffering from quite a lot of anxiety at the moment, due to this situation and also the fact I am trying wean myself off of an antidepressant as I will not be a hypocrite and take something which more than likely caused my daughter's problems. Having been on prescribed anti depressants since the age of 14, and only having stopped them for the period of my second pregnancy, that is 20 years I have put this medication into my system and I do not know how well my brain is going to function but we shall see. I find it appalling, now knowing what I know about ssris, that I have been encouraged to take something for a "chemical imbalance" in my brain which has not even been proven to be a cause of depression ect. I am suffering with horrible withdrawal symptoms and if the medication can cause this upon stopping them then what must they be doing to your brain to cause this. If you could let me know if you have a timescale in which you plan to reply it would be greatly appreciated.

Cheryl Buchanan

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18 Nov - Lundbeck to Cheryl

From: UK Medical Information
Sent: 18 Nov 2013 16:11:25 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

Please forgive the further delay in getting information across to you.  I have now received all the information back concerning your questions, and am just collating this for you.

I will make sure you receive a reply tomorrow.

With kind regards

Karen Warrillow

----

Nov 19 - Cheryl to Lundbeck

Date: Tue, 19 Nov 2013 15:33:53 +0000
Subject: RE: Email sent from Lundbeck.com
From: REDACTED
To: UKInfo@Lundbeck.com

Hi, just wondering if you have gotten any further on with regards to a reply to me questions?

Cheryl

----

Nov 20 - Lundbeck to Cheryl

-----Original Message-----

From: UK Medical Information
Sent: 20 Nov 2013 17:18:08 GMT
To: REDACTED
Subject: Information relating to citalopram (Request ID 0005-8858, UK 8637)

20th November 2013

Dear Ms Buchanan

Thank you for your recent emails.  Firstly, I would like to say how saddened we were to hear of your experiences.  I have addressed the questions that you raised, and hope that the information below helps to clarify things.

The methods of collecting and reporting safety data about medicines available in Europe are governed by Pharmacovigilance Regulations issued by the European Medicines Agency. I am sure you will probably have already done this, but you might find it helpful to have a look at the MHRA's information on the Yellow Card Process; this includes information on how reports are handled and what is done with the reports. This can be found at the following link; http://yellowcard.mhra.gov.uk/faqs/ .

Adverse events assessed as 'serious' reported by healthcare professionals and patients to the MHRA via the yellow card system are normally forwarded to the company responsible for inclusion in the company's safety database. The reports are anonymised by the MHRA before forwarding to us, so we are unable to then make contact with the patient concerned or the reporting healthcare professional. All pharmaceutical companies also have a process in place to forward on to the MHRA any reports received directly from healthcare professionals or patients . We also collect information on any cases of exposure to medicines during pregnancy, and whether or not problems are reported.

Periodically, at intervals specified in the safety regulations, companies must also submit a summary report of all safety-related information which has come to their attention, including reports of usage in pregnancy, to the regulatory authorities in the countries where a product is available (i.e the MHRA for the UK). The authorities review this information and make recommendations on whether the prescribing information (SPC & PIL) should be updated to include any information on newly identified possible side effects. The authorities may additionally sometimes request that SPCs are updated to incorporate new information which comes to light in the published literature about the medicine or similar products . In this way the SPC is a living document which at any one time reflects the currently known information about a medicine.

When looking at the figures provided in the Drug Analysis Prints (DAPS) on the MHRA website, it is very important to be aware that the figures listed are not necessarily cases where the event is specified as being causally-related to the medicine in question, in this case citalopram. The MHRA state themselves in their guidance notes about DAPS; "The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction." The listings do not provide further information about the cases reported which also need to be taken into consideration, such as any medical conditions the patient might have or details on other medicines taken, or take into account the likelihood that all of the events listed are also reported in the general population.

To put this information into context a little we know that worldwide more than 140 million patients have been treated with Lundbeck-manufactured citalopram over a 20-year period (and many more when generic preparations are included). This large volume of data includes cases of usage in pregnancy and through our frequent analysis and evaluation of this data reported to the company, and regularly forwarded to the drug regulatory authorities for their assessment, there is no evidence to indicate that usage of citalopram in pregnancy increases the risk for birth defects over the background risk. There are a number of reviews which have been published in the scientific literature which support this finding.

You are correct in stating that fairly recently we have added information on PPHN into our leaflet for Cipramil. This occurred in July 2010 and was the result of an assessment by the European Regulatory Authorities who evaluated three new epidemiological studies published in the scientific literature. These evaluated the pattern of PPHN occurrence across large defined populations and generated evidence to support the conclusion that the use of SSRIs in pregnancy, particularly in the later stages, may increse the risk of PPH in the newborn. PPHN may be casued by a number of factors, not necessariliy related to malformations and although the risk of PPHN is still very small, the risk is slightly increased in babies born to mothers taking antidepressants, such as SSRIs. Consequently the same wording was introduced to the pregnancy section for all the SSRI medication leaflets and SPCs in 2010. This quantifies the risk for clinicians and patients to try to assist decision making and is an example of the product information developing as more becomes known about a medication over time.

Medical treatment of pregnant women will always produce challenging clinical judgements, and whether or not to take a medication during pregnancy is a complex decision. A body of literature has now been published discussing the benefits and risks of antidepressants treatment during pregnancy. It should be kep in mind that depression and anxiety in pregnancy are risk factors for adverse outcomes for both mothers and their newborn children. It is also now known that untreated depression can itself affect neonatal growth and has also been linked to e.g. miscarriage, preterm birth, and impaired foetal and postnatal development.
As we mentioned in my earlier email, it would also be most helpful if you would report your experiences. I have re-attached a consent form for you to sign and return to us. If you do not wish to do this directly to us, you could submit a yellow card report yourself directly now to the MHRA via their website; http://yellowcard.mhra.gov.uk/. If you do this, if you quote the Reference ADR 10748808, they will add this information to the original record that was reported in 2004.

Kind regards
Karen Warrillow
Medical Information Manager
Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

Dec 12 - Cheryl to Lundbeck

Date: Thu, 12 Dec 2013 10:11:26 +0000
Subject: RE: Information relating to citalopram (Request ID 0005-8858, UK 8637)
From: REDACTED
To: UKInfo@Lundbeck.com
CC: REDACTED

Dear Lundbeck,

Thank you for taking the time to reply to the question I posed to yourselves. I do not, however, feel that any of them were clearly answered, in fact all of the information you stated I had already found for myself by researching online. I do understand that you cannot admit any facts that can be used to hold you responsible for my daughter's death but I did expect, considering the time you took to respond, that there may have been something which was new to me.

I have asked the MHRA under the freedom of information act for all correspondence between them and yourself in which my name is mentioned. I would like to ask if the MHRA have contacted you recently about my case I have submitted yet another yellow card.


In response to the following statement,

"When looking at the figures provided in the Drug Analysis Prints (DAPS) on the MHRA website, it is very important to be aware that the figures listed are not necessarily cases where the event is specified as being causally-related to the medicine in question, in this case citalopram. The MHRA state themselves in their guidance notes about DAPS; "The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction." The listings do not provide further information about the cases reported which also need to be taken into consideration, such as any medical conditions the patient might have or details on other medicines taken, or take into account the likelihood that all of the events listed are also reported in the general population. To put this information into context a little we know that worldwide more than 140 million patients have been treated with Lundbeck-manufactured citalopram over a 20-year period (and many more when generic preparations are included). This large volume of data includes cases of usage in pregnancy and through our frequent analysis and evaluation of this data reported to the company, and regularly forwarded to the drug regulatory authorities for their assessment, there is no evidence to indicate that usage of citalopram in pregnancy increases the risk for birth defects over the background risk. There are a number of reviews which have been published in the scientific literature which support this finding."

I would like to clarify your position, are you telling me that citalopram was not to blame for any of the cases referred to in the DAP?

I would also like to invite you to read a guest blog I wrote for Bob Fiddaman's blog? I will pop a link for you below. If you would like to reply on the blog please feel free to leave a message.

http://fiddaman.blogspot.co.uk/2013/12/citalopram-birth-defects-guest-post.html


I will be cc ing Mr Fiddaman in on all correspondence from now on. I hope that is not a problem.

Cheryl Buchanan

----


Lundbeck have yet to reply.

I think it's important that we, as patients, query the drugs we are given when things go wrong. In Cheryl's case she lost a child. She has a right to question Lundbeck as they made the drug that Cheryl claims caused the birth defects.

It's also important to post emails publicly because other women who have taken citalopram and whose children were born with defects or whose pregnancies were terminated may just make that link and may also start to throw questions at Lundbeck.

Without mothers coming forward and reporting their adverse events to Lundbeck they can always turn a blind eye to something that has been staring them in the face for many years. Lundbeck, just like their rivals GlaxoSmithKline, have produced a drug that can cause birth defects. Instead of warning the public they choose to send meaningless emails to those whom question their drug. So be it. The more uncaring and meaningless emails they send, the more uncomfortable questions they will have thrown at them.

Cheryl is a tenacious woman. I think she is going to be around for a very long time. I think she is going to keep on asking Lundbeck those uncomfortable questions. I think she's right.

Bob Fiddaman


Speaking of emails...

I've been sitting on some Paxil ones for a few days. I'll release my findings soon.

Citalopram Birth Defects (Guest Post)

Pictured - Scottish Mom Cheryl Buchanan

For the past week or so I have been speaking with a mother who terminated her pregnancy because she was told her fetus had severe birth defects. That woman, who at present I can't name, was taking Paxil. It's a future story for this blog.

About two weeks previous to the Paxil contact, I received an email from Cheryl Buchanan, another mother who had a similar story to tell, this time the drug involved was another SSRi, citalopram, also known as Cipramil and Celexa.

I asked if she would like to write a guest post for my blog, she agreed. I'm glad she did because she writes beautifully.

I really don't have much to add to Cheryl's story other than I admire her for speaking out. Far too many of these birth defect cases are settled by pharmaceutical companies in courts throughout the US. To bring such cases to Great Britain is notoriously difficult, such is the pharmaceutical industry's stranglehold on the UK government policy to fund such litigation.

In the US, the same pharmaceutical companies are sued, they settle with the plaintiff on the proviso that the plaintiff keeps quiet about the terms of that settlement. By keeping these 'gagging orders' in place it allows them to continue pushing the drug on pregnant mothers, it allows them to to quicken their pace to the end of the statute of limitations... meaning that no other cases can be brought against them.

By not allowing such litigation in the UK, or by the government putting blocks on legal funding for these types of cases it could just be the chink in the armour for activists like myself and for those who wish to seek justice.

No pharmaceutical company likes it when they are accused of putting pregnant women at risk, they don't like it when they are accused of forcing the hand of women to have abortions either.

I believe the following will help more and more mothers speak out.

This is Cheryl's story...

Bob Fiddaman.

"I will lend you, for a little time,

A child of mine, He said.

For you to love the while he lives,

And mourn for when he's dead.

It may be six or seven years,

Or twenty-two or three.

But will you, till I call him back,

Take care of him for Me?"

(A child of mine - Edgar Albert Guest)

God lent me my child, physically, for 23 weeks. Now she is back in the arms of the lord but also tucked away in my heart for eternity. She never got to take her first breath, I never got to see her smile or hear her cry. My child was born, and died, at 23 weeks gestation of pregnancy. I was told she had severe abnormalities which meant she  was incompatible with life. There was no explanation as to why it might have happened, the words "it just wasn't meant to be" did not console me, they angered me. Why did God choose my child, what had we done to deserve this? I was so angry with God, but I placed blame for it on myself. I hated myself for failing my child. For nine years I gave myself hell, mentally berated and tortured myself. I thought if I stopped feeling so bad, my daughter might think that I didn't love her as much. Now I am suffering in a different way, I discovered not long ago that my child may have developed congenital abnormalities because of a medication called Citalopram, which I had been prescribed before and throughout pregnancy. Shockingly I also discovered that I am not alone and every day pregnant women are still being prescribed antidepressants.

Since I was a child I suffered from anxiety, as a teenager I was prescribed Prozac (Fluoxatine), due to being bullied at school. I took them on and off for a few years, my family went through a series of bereavements, I did not cope very well. I was admitted to a psychiatric unit 3 times at the age of 22. I was diagnosed with psychosis and Bi-Polar disorder. Looking back I know now it was caused by grief, I did not have Bi-Polar disorder. I was given the usual concoction of anti psychotic medications (Risperdal, Olanzapine,Effexor). I was unwell for around a year but got off of the medication, was in a good place mentally and had the support of my lovely partner. Then suffered more bereavement in our families. This time I did not let the grief overwhelm me as it had done before, this time we decided to do something to try bring some happiness back into our lives, we decided to try for a baby. I informed my GP who prescribed folic acid for me, I was also taking prescribed Citalopram, at a dose of 60mg, a dose which is no longer prescribed as its known to cause heart problems in adults. The GP told me it was fine to keep taking it so I carried on, completely oblivious to the damage I was about to do to my unborn child.

Within a couple of months I discovered I was pregnant,  the time flew in until the 12 weeks scan, I so exited to see my baby for the first time, I had no fears, didn't know that it was possible for things to go wrong, now I realise how incredibly naive i was. The sonographer was carrying out the scan, pointing out my daughters heart, head ect but then stopped and became very quiet, I asked what was wrong but she excused herself from the room, went to get a consultant to speak to me. That was the beginning of the end, after only 12 short weeks of existence they could already tell me daughter was very ill. The scan, and subsequent scans, detected a series of anomalies. The most severe of which included suspected diaphragmatic hernia or eventration, long bone immobility (I had never felt her move but as this was my first pregnancy I didn't know, I had nothing to compare it to), a cystic hygroma, unilateral cleft hand and microgynathia. I was also told that she might have brain damage which would explain the fact she didn't (or possibly couldn't) move.

The post mortem revealed half of my daughter diaphragm was absent, her lungs were very small, some of her organs had moved up into the thoracic region. Her neck had webbing, nose was small, chin recessed.  No one could tell me why this had happened, my consultant tried his best, geneticists looked at my files but no one had a reason why my baby's development had gone so catastrophically wrong. I was thoroughly reassured citalopram was not to blame. My daughter was cremated two weeks after her birth, it was all arranged by the hospital, we had a service for her at the crematorium and I will never forget the image of her being carried down the aisle in her coffin, going through the curtains to be cremated. I wanted to run over and stop them, grab my daughter and run away. Previously I hadn't thought it possible for any human to ever experience the amount of pain I suffered and survive.

After the cremation I was told to collect the ashes the following day, when I called I was told there were no remains. I was devastated, I just wanted something of her, something physical that said she had existed. In January of this year I found some news articles from Edinburgh that Mortonhall Crematorium had routinely been retaining baby's ashes, telling the parents there were no remains, then "interring" them in a field. Immediately I thought of my daughter, although I live in Glasgow I decided to try and find out if this practices had occurred here too. Quickly I discovered my gut instinct was right, I found other parents in Glasgow who had recently discovered their baby's ashes had to been returned to them and scattered by the staff at Daldowie Crematorium, the place my daughter was cremated. We have been working hard to convince the Scottish Government that a public inquiry is necessary, so far however, our pleas to The First Minister and Scottish Government, have fallen on deaf ears. At the moment Lord Bonomy is heading up a "Cremation Commission" looking into ways in which to change cremation practices in Scotland, also in Edinburgh Dame Eilish is carrying out an investigation into the practices at Mortonhall crematorium. Through my own investigation I asked the Princess Royal Maternity Hospital for a copy of my records from the time of my pregnancy. Now this is where the fun really begins.

Upon receipt of my records I noticed a photocopied page of something called a "Yellow Card Warning", it was sent by my consultant, to the MHRA, advising them of the outcome of my pregnancy and that i had been taking Citalopram. I was devastated when I looked through my records, I had to read through her post mortem, several letter from my consultant to geneticists and other information that realistically, I should never have had to see. I googled "citalopram birth defects" and was horrified to find that there were 385,000 search results, I also discovered the existence of Lundbeck, a Danish pharmaceutical manufacturer, the inventor of citalopram.

My blood was boiling, I had to do something so I contacted just about everyone and anyone who had a blog or website dedicated to the side effects of SSRI's. I was very lucky to have found some wonderful people, people who had suffered because of these drugs, people who had lost loved ones to them. I also contacted the Centre for Adverse reactions in Scotland (they were useless), Lundbeck were next on my list so I asked them series of questions, I don't think they answered even one of them. The majority of their reply was information I had already found on the internet, total garbage I could have copy and pasted myself. Once of the points I made to them was "My daughters lungs were a third of the size they should have been, she had pulmonary hypoplaisa due to diaphragmatic hernia. Pulmonary Hypoplaisa is a known cause of Persistent Pulmonary Hypertension of the newborn (PPHN), so its quite reasonable to say my daughter would have had this condition had she been born alive, had she had it, it would have been down to the citalopram." If this was to be the case then Lundbeck would have been held responsible, after all they have it stated on the Patient Information Leaflet the "SSRI medications of this type can cause PPHN". They dodged that question, just like every other one. To me, its blatantly obvious citalopram killed my child. Had she been born alive she would have not been able to breath and would have endured an intolerable amount of suffering. Lundbeck also said in their reply that when prescribing SSRI's in pregnancy "the benefit has to outweigh the risk". I do not believe, prior to my pregnancy, that I was suffering from depression, quite the opposite in fact. I would have happily stopped the citalopram had I been advised that it can cause birth defects. In fact with my second pregnancy, although I did not know anything about citalopram causing these problems, I stopped taking it the day I found out I was pregnant, I was not taking any chances. I now have a beautiful, healthy seven year old daughter but every so often I look at her and feel intense sadness at the fact I should have two children on earth with me.

At this moment in time I am a bit lost. I have been told that it will be very difficult to have a case against Lundbeck heard in court but that doesn't mean I cant try. I have to do something, my conscience wont sit still for a second, it always on at me to look for more info, ask more questions. At first I was in shock at all of this now I believe my child was "lent" to me for a reason. God must have known I would fight, not just on my own behalf but on the behalf of every parent and child affected by these drugs.  He must have known the intensity of the love I would have for her, I am very blessed and humbled that he chose me. My daughters death will not be in vain, I will not back down until those responsible are held to account. In may of next year some of the Class Action Lawsuits against Forest Laboratories (a license holder for citalopram in the USA) are due to begin. I am hoping this will shed more light on the ill practice of Lundbeck and Forest, I am hoping it will pave the way for parents like myself to bring similar actions in the UK. I want to make one thing clear tho, I am not doing this for money, it means nothing to me. All the money in the world wont bring my daughter back. What I want is for SSRI medications to be reclassified as a class D drug. Also an apology, an acceptance of guilt would be nice.

Guess I better not hold my breath...

Cheryl Buchanan

Glasgow, Scotland



Coming Soon - GlaxoSmithKline's attorneys, King & Spalding, argue a fetus is non-viable if under 23 weeks old. A truly shocking story of injustice regarding a mother forced to abort because of birth defects caused by Paxil.