The Homicide Files: Celexa & Lexapro

Following on from my last post, The Murderous Pills and The Keystone Cops (FDA), which highlighted 6 cases of Paxil related homicide, I now turn my attention to Celexa, known in Europe by its brand name of Cipramil and better known as its generic name of citalopram. Also included is the sister drug to Celexa, namely, Lexapro, known in Europe by its brand name of Cipralex and better known as its generic name of escitalopram.

Once again I will highlight just 6 cases of prescripticide* ~ there are many more in the Murder Meds database.


AERS Case Number 6301497

Homicide by male (age unknown. The patient was taking Celexa (40mg per day) between October 2003 to an unspecified date.

This was sent to Medwatch from a court clerk who had heard the evidence of the accused at trial. Pay particular attention to the side effects leading up to the murder. (Click on images to enlarge)

http://www.murdermeds.com/index.php/2016/01/30/aers-case-number-6301497/

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AERS Case Number 7574444

Homicide by male (78). The patient was taking Celexa (20mg per day) for just 5 days.

Notice, in the report, how his whole mood changed once he started Celexa therapy.

http://www.murdermeds.com/index.php/2016/01/22/aers-case-number-7574444/

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AERS Case Number 5850018

Homicide by male (54). The patient was taking Lexapro, unknown dosage, over a period of 2 to 4 weeks.


As you will see, the patient had no prior history of violence or aggression.

http://www.murdermeds.com/index.php/2016/01/16/aers-case-number-5850018/

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AERS Case Number 7274376

Homicide by male (37). The patient was taking Lexapro, 10mg, over a short period of time before he shot and killed his girlfriend and critically wounded a young man. He then failed in his own suicide attempt.

http://www.murdermeds.com/index.php/2016/01/21/aers-case-number-7274376/

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AERS Case Number 6044971

Homicide by male, 55, (Initially the report said he was 40 but this was later rectified)  The patient was taking Lexapro, unknown dosage, over an unspecified time before he shot and killed his wife.

Remarkably, his treating physician did not consider that Lexapro played any part in the, seemingly, induced psychosis. Something that truly baffles me given that this is based on an assumption of the doctor and not scientific evidence.

http://www.murdermeds.com/index.php/2016/01/17/aers-case-number-6044971/

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Finally, the last case is familiar as it concerns 22 year old Shane Clancy from Ireland. His name is omitted from this report. After reading it may be worth listening to the podcast (Link after images) 3 pages of the 6 page report have been redacted (for reasons unknown)

Shane was on citalopram for just 17 days.

AERS Case Number 7164838

(Listen to Podcast for full details)

http://www.murdermeds.com/index.php/2016/01/21/aers-case-number-7164838/

The above case is explained in great detail in the following Podcast recorded between myself and Shane's mother, Leonie Fennell, back in 2011.

Bob Fiddaman.

*Prescripticide ~  is defined as a death that is caused by an adverse reaction to a prescription drug.

Previously in this Homicide series...

The Murderous Pills and The Keystone Cops (FDA) - Paxil

Database available on Murder Meds.

This blog post is dedicated to the memory of Shane Clancy.

Q&A With Leonie Fennell

Imagine, if you will, a Sunday morning. You have that extra hour in bed with your partner. You can hear the kids downstairs playing, the TV is blaring, their laughter makes you smile.

You climb out of your slumber and head for the kitchen, breakfast is soon on the go and you all sit down as a family to eat.

Imagine, if you will, a knock at your door. On answering you see two police officers.

They are the bearers of bad news ~ they tell you that your son is wanted for questioning, moreover, they tell you that he is suspected of killing someone.

Imagine, if you will, during this visit a message comes through on one of the officer's walkie-talkies. "We've found the suspect, he's at the rear of the property... he's dead."

The unthinkable.

Leonie Fennell and her husband Tony don't need to imagine. This is their reality.

I first met both Tony and Leonie at an award ceremony in East Grinstead. We stayed up until the small hours talking about their son, Shane. It, for me, was heart-wrenching to hear and see two broken parents, particularly as my roots stem from Ireland (my mother being born and raised there)

We kept in touch and I've popped across the Irish sea to see them both on a number of occasions. Words cannot describe this beautiful couple, this beautiful family ~ all plodding along after such a tragedy. I've met Leonie's extended family too, a wonderful bunch (clan) who made me feel so welcome.

Leonie, as you will see from the Q&A's, has been very vocal in her mission to raise awareness about antidepressants. Shane was just 22 when he broke up with his girlfriend. He was heartbroken - he was prescribed the powerful antidepressant, citalopram (known as Celexa in the US). A month or so later Shane committed homicide and then killed himself, two acts brought on by induced psychosis, an adverse side effect of citalopram.

Tony and Leonie have been a part of my 10 year journey with this blog. I love them both dearly.





Full name: Leonie Fennell
Age: 50
Location: Wicklow, Ireland.



Q: Leonie, now that you have established yourself as a blogger, do you feel that your work over the years has brought about change in the way that many feel about antidepressant use?

A: Surprisingly, I do. The feedback suggests that the public are far more enlightened to the harms that come directly from putting harmful chemicals into our bodies. It has taken a long time for people to realise that medicines (prescribed by a friendly GP), while often doing good, can equally cause huge harm. When I started out in 2009, antidepressants were mainly seen as harmless happy-pills. People now seem far more cautious and whether they believe me or not, is irrelevant. Being aware of issues can often mean an adverse reaction is recognised for what it is - caused by the drug and not the supposed ‘illness’.  I think, in Ireland at least, largely due to the work of Irish doctor David Healy, people are questioning over-medicalization, particularly of our children. The tide is definitely turning on the pharmaceutical industry.


Q: They say that behind every good woman is a good man (or something like that). Your other half, Tony, has, I know, been a tower of strength for you and your family. How important is it, for you, to have the support of Tony?


A: He’s amazing - my rock. Don’t tell him I told you though, wouldn’t want him to get a big head. Joking aside, Tony has kept us all going, through thick and thin, through the laughter and the tears. He’s like a big soft cuddly toy - a bit battered and bruised, but totally-loved teddy bear. He was a broken man when Shane died and while the scar tissue must surely be visible under a microscope, he’s survived to battle on, especially for Shane. As a family we still laugh often - sometimes at Tony, but usually with him. I think he quite likes it.

Q: Back in 2011 you and Tony travelled to Denmark to meet with Lundbeck. The subject matter, in the main, was about citalopram (Celexa), the antidepressant that induced psychosis is your son, Shane. Can you tell me more about that meeting and how you feel it went?

A: To be honest, it wasn’t too surprising. I think the Lundbeck officials we met actually expected us to accept their denials and walk away hand-in-hand into the Copenhagen sunset. Instead, they just confirmed what we knew already, that most pharmaceutical companies will lie and cheat in order to cover up the harms done by their chemicals. The many deaths, like Shane’s, are brushed aside as collateral damage, a nuisance. The meeting was a bizarre experience.

Q: On average, how much time do you spend with work that relates to your blog?

A: Many, many, hours. I could often spend entire days doing research, which may or may not turn out to be useful. It’s my form of relaxation and I could quite happily sit in the midst of chaos while working on a particular subject.

Q: 2011 was, it appears, a busy year for you. In the summer of that year you were contacted by solicitors with regard to something you wrote about Irish psychiatrist, Patricia Casey. Can you tell me what all that was about and what was the outcome?

A: Casey is probably one of Ireland’s most widely recognised psychiatrists. She often sends people solicitor’s letters when she gets offended – which is quite frequent. I have never been reticent about being shocked and distressed when she commandeered Shane’s inquest, arriving uninvited to offer her assistance to the coroner. After her offer was ignored, she then wasn’t happy with the jury’s decision (an ‘open’ verdict). Directly after the inquest, on the steps coroner’s court, she proceeded to speak to the waiting media, stating there were aspects of the evidence that the college (of psychiatry) took issue with. I think her issues were with Dr David Healy, who testified that these drugs can be dangerous, in particular that SSRI antidepressants can cause suicide and violence. Later, she took offence against a blog I wrote about her and sent me a solicitor’s letters for my troubles. I then published the letter saying I would not be bullied or intimidated by Lundbeck or anyone else – so she sent me another one and I published that too. I think you know you’re on the right track when you get a ‘Casey Correspondence’.

Q: Congratulations on graduating with a law degree. It's a wonderful achievement. What made you decide on studying law?

A: I started studying law the year after Shane died. I basically wanted to find out how the pharmaceutical companies were getting away with harming people on this side of the Atlantic, when in the U.S. cases are regularly settled or the pharmaceutical industry are found guilty. Same drugs, same humans but warnings provided in the U.S. and none here – it’s a ridiculous situation. There will be no accountability until the legal system and our governments takes steps to sanction wrongdoing by these enormous companies. At the moment companies like GlaxoSmithKline and Lundbeck are being permitted to run rough-shod over Europe. The law degree helped me to understand the situation, but not accept it. I should say though, that I thoroughly enjoyed every second of doing law with my lovely colleagues and lecturers -  it was a great distraction.

Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant induced suicide?

A: I certainly would. Apart from being another great distraction, it’s a cheap form of therapy. It helps to get things in perspective and enables many diverse conversations. I do know that my family was helped enormously by other bloggers, particularly you and Truthman. It’s such a huge revelation when you find others in a similar situation, having thought you were alone. Sadly, there are many more victims and bereaved families since – yet, as there are more experts willing to speak out (Peter Gøtzsche for example), I think positive changes are coming fast.

Q: As an outsider looking in (kind of) I am amazed at your commitment and tenacity. What is it that keeps you going?

A: That’s easy – Shane. He was just so lovely, kind, funny and caring. I think of him every second of every day and the injustice of his death keeps me going. He was very like me and would have fought many injustices in his 22 years. I believe with every fibre of my being that Shane died because of Citalopram.  Therefore, I could never have moved on, taken the other option - to live a relatively easy life, albeit one without Shane.  To do that would have been to actively enable similar deaths to happen to others. It was never an option. It helps that there are so many of us in the same boat, helping each other out.

Q: Have you ever considered writing a book about your journey?

A. I have and it’s about 2/3 of the way finished. It’s just a matter of time, which I never seem to have enough of. The goalposts keep moving, with so much emerging pharmaceutical information. Shane’s personal story is fighting with my academic side and I’m trying hard to marry both and still keep it interesting.

Q: What do you say to people who believe that antidepressants are safe and effective?

A: Some people seem to be able to take antidepressants without coming to any harm. Whether through the placebo effect, or otherwise, some say they are helped by them. There are many reasons for this, not least that people usually get better with or without medication. Nevertheless, we know that these drugs are neither safe nor effective for the majority of people that take them, with experts saying they are causing ‘more harm than good’. We know they can double the risk of suicide and violence, cause mania, increased depression and a myriad of other harmful effects, including heart problems and stroke (causing many fatalities). Two innocuously-sounding effects that fascinate me are emotional-blunting and disinhibition – effectively meaning that a huge percentage of people could be walking around with sociopathic tendencies. No doubt future generations will look back and see this era of mass-prescribing, as ludicrous. I would advocate vehemently for fully-informed-consent, a practice sadly lacking in Europe.

Q: I see from your Facebook profile that you have an annual dip in the river each December. Can you tell me more about that and other charity work that you are involved with?

A: My family do the Christmas Day swim in Sandycove every year, to raise money for the Simon Community. I don’t if I can get away with it and instead, I pay to get out of it. I spend from January to December dreading it, so I bribed Tony into doing it last time and happily looked on from the side-lines at all the blue bodies. For some strange reason, one that I could never fathom, my mother, brothers, sisters and cousins love jumping into the freezing Irish sea – I don’t.

Q: When I spent time with you and Tony in Ireland you told me about Shane's gesture on his 21st birthday. (Church) For the benefit of this Q&A can you tell the readers about this wonderful gesture?

A: It wasn’t the church, it was the St Vincent De Paul, a charity he was very fond of - he worked there as a volunteer. Shane was very kind-hearted, always eager to help those who were unable to help themselves - so much so that he was referred to by his lecturers as ‘an chroi mór’ (Irish for the big heart). For his 21st birthday party in 2008, Shane asked everyone to make a donation to the St Vincent de Paul rather than buy him a present.  He told everyone he didn’t need presents, that he had everything he could possibly need.  He wrote the following words on his official 21st party invites...

“…despite the fact that my parents neglect me [joke], believe it or not I am spoiled.  So instead of spending money on a card or anything else, please make use of the St. Vincent de Paul box on the night where you can give the money to someone who needs it as I have everything, thanks. Shane”

Q: For you, what is the most frustrating part about being a patient advocate?

A: What frustrates me most is lackadaisical journalists who come looking for newspaper fodder. They often look for contacts details (of medical experts and bereaved parents) and I’ll happily do what I can to help. Occasionally though, they look for ‘all the up-to-date evidence’ and I can spend days doing research, effectively doing their job for them. Nevertheless, I persevere just because I’m thankful that iatrogenic harm will be discussed – how sad is that? I wish there were more good scientific journalists, who would use their own initiative and do their own research. We could do with some good medical and science writers over here – I wonder could we adopt Robert Whitaker or Mikey Nardo?

Q: Where do you see yourself in 10 years time?

A: Besides pottering around Wicklow with Tony, having recovered from the empty-nest syndrome and if I haven’t kicked the bucket, I see myself teaching Pharma-Ethics (unethical ethics), or something similar. I hope to put my years of studying, research and life-experience to good use and have many projects in the pipeline. However, I wouldn’t have predicted living the life I now lead, so who knows?

Q: Finally Leonie, some personal questions...

1. What book are you currently reading?

A: I’m studying at the moment, so the book that comes everywhere with me is ‘Principle of Biomedical Ethics’ by Beauchamp and Childress. It’s actually not as bad as it sounds.

2. What was the last CD you listened to (in full)?

A: The Best of John Denver (in the car while I waited for the boys to come out from Jiu-Jitsu training).

3. What is the best movie you have seen this year?

A: ‘Daddy’s Home’ with Will Ferrell and Mark Wahlberg (in the cinema with my 17-year-old son Jack). Absolutely Hilarious - although I think Jack was a little mortified in certain parts.

4. What country would you most like to visit?

A: Italy. We went for a day-trip to Ventimiglia last year (from Monaco) and it was just so incredible. It made us want to return to see more: the old buildings, the markets, the food, the people, the sun, the double decker trains –  sweet memories!

5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?

A: Not sure I understand the question, a good lawyer should do both I think. While we’d all love to change the world like Erin Brockovich, if the defending lawyer doesn’t defend the accused to the very best of his ability (particularly if he believes him to be guilty), that may leave the option open for a re-trial or a mistrial. We can all have subjective opinions, but a good legal system should be based on objectivity. HOWEVER, I can’t say I’d be very objective if I was to represent a victim of the pharmaceutical industry.



Leonie Fennell Blog

Leonie's Twitter Page



Bob Fiddaman



Previous Q&A's

Q&A With Ablechild's Sheila Matthews-Gallo

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?

Two Facebook Statuses That Say It All

Seroxat (Paxil) withdrawal...

If you, like many thousands, find difficulty when trying to wean yourself off Seroxat (known as Paxil in the US and Aropax in Australia) then you'll know that there is no guidance.

The manufacturers, GlaxoSmithKline, refuse to help - Any correspondence sent to them during your horrific withdrawal will be met with the bog standard replies of "We are not allowed to discuss individual cases blah, blah..."

Your prescribing healthcare professional will, more than likely, refer to the product monograph which really tells them that there isn't a huge problem when patients taper from Seroxat - the product monograph, if you didn't know, is crafted by the drug company.

The medicines regulator, be they the British MHRA, the American FDA or the Australian TGA, will shrug their shoulders then scurry back to their various rat holes in the hope that you don't disturb them again.

Internet forums will offer various tidbits of information, you'll show your prescribing physician and he/she will probably tell you that these types of forums are run by conspiracy theorists.

~Bob Fiddaman


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As I was getting nowhere debating back and forth with the MHRA and Pharmaceutical company Lundbeck I decided to write to the Minister for Public Health, Jeremy Hunt, about my daughters death which I believe was caused by the SSRI Citalopram. She was fatally malformed, incompatible with life. I had been given a "prescribed overdose" (according to lundbeck) by my GP unwittingly throughout the pregnancy and thoroughly reassured that it was not a teratogen. I was on a prescribed dose of 60mg, this dosage was the maximum back in 2004, but was lowered a few years ago to 40mg by the manufacturer and the MHRA as it was known to cause the heart condition "Long QT syndrome" and sudden death in adults. Today I was very surprised to have received a response -

Dear Miss Buchanan,

Thank you for your correspondence of 5 October to Jeremy Hunt about citalopram. I have been asked to reply.

I was very sorry to read about the death of your daughter and the circumstances surrounding her cremation.

However, the Department of Health is unable to comment on individual cases.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided the following information.

Citalopram is a member of the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are used to treat depression in pregnant women in cases where there are no safer alternative effective treatments. The decision to prescribe SSRIs requires a careful evaluation of the need for treatment and any known risk of harm to the mother and/or foetus. Untreated depression during pregnancy is known to be harmful to the mother and foetus.

Some studies have suggested a small increased risk of birth defects with some SSRIs. Data has shown that paroxetine and fluoxetine are associated with an increase in risk of birth defects in the baby if the mother takes them in the first trimester. The background rate for birth defects is two to three per cent of all pregnancies. Current available data is insufficient to prove birth defects occur more commonly after taking citalopram than this background rate.

It is known that all the SSRIs can be associated with an increased risk of persistent pulmonary hypertension, a heart condition in the newborn, when taken later in pregnancy. Neonatal withdrawal and toxicity reactions have also been reported when SSRIs are taken in later pregnancy.

Several important changes to the citalopram prescribing information were introduced by the MHRA in 2011, including maximum dose restriction in adults after a detailed review of data showed citalopram was associated with a dose-dependent increased risk of abnormal heart rhythm.

The MHRA continues to monitor the safety of use of SSRIs in all patient populations very closely and all new data are rigorously assessed to evaluate the need for further regulatory action.

I am sorry I cannot be more helpful, but I hope this reply helps to clarify the situation.

Yours sincerely,

Malcolm Jones
Ministerial Correspondence and Public Enquiries
Department of Health

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I'm sorry to see that, once again, I have been given the usual spiel about the MHRA monitoring medications such as these, but what use is monitoring them if, when issues are flagged up, they chose to do absolutely nothing about it? I have never had once single invitation from the MHRA to converse with them or provide them with further information on my daughters death, this is despite me contacting them fairly regularly for over the past two years.

What else can I do? Is there anywhere else I can turn, anything I can try? I'm not giving up on this. I won't ever give up.


Cheryl Buchanan


--


Says it all really...



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]