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Wednesday, August 27, 2014

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.