This morning I came across a Freedom Of Information e-mail that I had received from the IMB. It was a copy of the Adverse Reactions Reports (ADR’s) relating to Cipramil. I noticed that there was a intrauterine (inside the womb) baby death reported. The death of this baby was attributed to “exposure to Cipramil during pregnancy.”
Teratogen; An agent, such as a virus, a drug, or radiation, that can cause malformations or functional damage to an embryo or a fetus.
In Ireland women get very little warning about the teratogenic effect of these drugs. Psychiatrists and GP’s seem reluctant to voice their opinion one way or the other. Whether this is because they don’t want to bite the hand that feeds them or because they believe the drug company spiel is anyone’s guess. Either way, spouting about the benefit/risk conundrum is clearly a get-out clause while in the meantime babies are dying.
In 2010 there was a Case in the High Court, where a little girl’s parents alleged that the disabilities she was born with, were caused by prescription drugs taken by her mother during pregnancy. The Case was settled without admission of liability for €500,000. Article.
I’m not an expert so can only give my opinion but Professor Healy is, so here is what he says: “In the case of the SSRIs as the evidence mounts that these drugs cause birth defects, doubling the rate of major malformations, doubling the rate of miscarriage, increasing rates of voluntary terminations and more than likely leading to learning disabilities/autism in a significant number of children born to mothers on these treatments, we have nevertheless a mounting use of these drugs.”
Here is an excerpt from Professor Healy’s talk “The Cardinals Of Psychiatry” Full Paper here.
Final Acts of the Tragedy
We are facing a true tragedy – a system put in place with the best of intentions to prevent injuries from drugs in general but symbolized in particular by injuries to babies in utero is now leading to just the outcomes it sought to avoid.
In the case of the SSRIs as the evidence mounts that these drugs cause birth defects, doubling the rate of major malformations, doubling the rate of miscarriage, increasing rates of voluntary terminations and more than likely leading to learning disabilities/autism in a significant number of children born to mothers on these treatments, we have nevertheless a mounting use of these drugs. Where antidepressants were once used rarely in pregnancy they are now among the most commonly used drugs – up to 15% of pregnant women.
This use is actively promoted by our Cardinals, who collectively make it almost impossible for articles to get published drawing attention to the issues. It is a world where articles can only get published in Vogue or other such outlets – outlining the case of Gina Fromm who for instance when she became pregnant in 2004, did a range of things that few women would have done in 1962 – she took cold rather than hot showers in case she might harm her baby, stopped eating yoghurts and incinerated any chicken because of the risk of bacteria from listeria to salmonella. She balked at taking prenatal vitamins, though she had been taking Paxil following a fleeting episode of anxiety. She continued to take it through her pregnancy; she had found stopping difficult and her doctor reassured her it posed no risk to her baby. On February 2nd 2005 her son Mark was born with congenital heart defects.
The Death of the baby in the IMB e-mail was associated with Cipramil. We asked Lundbeck if their drug was a Teratogen. Although they seem to admit it, here is a prime example of drug company spiel….
Leonie Do you think that it’s advisable to virtually bathe foetuses in Serotonin given it is now accepted this family of drugs are firmly associated with birth defects?
Dr. Madsen Virtually bathe?
Leonie Foetuses in Serotonin – pregnancy.
Tony Pregnant women.
Dr. Madsen I don’t know what you mean by virtually bathe
Leonie I’m talking about anti-depressants are known to cause birth defects. If you think so, would it not be better if women of child-bearing age were cautioned against, perhaps even contra-indicated from using this drug? Citalopram or Escitalopram?
Dr. Madsen Em, I think in…..
Leonie Your views?
Dr. Madsen In pregnancy?
Mr. Schroll the medicines agency authorities you can see what is in the checks that the Doctors and that is up to them to decide…..
Leonie So you are passing the buck back to the Doctor again.
Mr. Schroll I think when it’s prescription medication, yes. If it was eh, eh,
Leonie And will they be told that it can harm their unborn baby?
Mr. Schroll Sorry?
Leonie Will the pregnant woman be told that the drug can, can harm her unborn baby?
Dr. Madsen Em, I think em, physicians need to double their efforts to make sure that there is a correct risk versus eh, benefit eh, assessment of the em, of any action.
Leonie Is Citalopram and Escitalopram a teratogen?
Dr. Madsen Em, meaning, what, what, what do you mean?
Leonie Can it cause harm to foetuses? Unborn babies.
Dr. Madsen Em, obviously, in order to have our compounds approved we have done em, a large number of pre-clinical trials em, and we are constantly monitoring and the eh, while the recommendation I believe throughout, is to be, be extra cautious when administering any eh, medications to pregnant women…
Leonie Can it cause harm…..to unborn babies?
Dr. Madsen Anything can cause harm, can cause harm in any dose…
Leonie So yes it can.
Dr. Madsen depending on dose
Leonie Yep…………Em, why if it can cause harm, is this not clearly, clearly stated on the packaging and information leaflet?
Mr. Schroll Do you talk about the patient leaflet or do you talk about the SPC, the label that the Doctors use in order to prescribe the medication?
Leonie I’m talking about a pregnant woman that goes down and gets it in the chemist. Is it on the patient information leaflet?
Mr. Schroll In the patient leaflet it says you have to talk to your Doctor….
Leonie And what does it say in the Doctor’s leaflet?
Mr. Schroll That he has to be extra cautious. I think that if you go to the… to, to the Irish home page, I believe it is like that, it’s like that in Denmark and elsewhere. If you go to the medicines agency authorities
Mr. Schroll It would be part of the discussion to talk about the risks and the benefits and that would be up to the Doctor.
Leonie It would be up to the Doctor to tell them that the drug can harm their unborn baby?
Mr. Schroll Eh, now, you’re talking…..
Leonie It’s not up to Lundbeck, no? It’s up to the Doctor to tell the woman that the drug can harm their unborn baby?
Mr. Schroll To be cautious, yes, yes.