cipramil (celexa) stories,, lundbeck, Newspaper and internet articles

Panorama Expose on Citalopram use in Pregnancy.

Unhappy pill

Next week BBC’s Panorama team are tackling the issue of antidepressant use in pregnancy. The programme will be broadcast on Mon 1st july, entitled ‘The Truth About Pills and Pregnancy‘.

According to the UK Independent “The programme will broadcast an interview with Anna Wilson, whose son David spent the first five weeks of his life in hospital. A 20-week scan had shown that David had a heart defect and would need surgery immediately after being born. Anna had been taking the prescription drug Citalopram to treat her anxiety four years before her pregnancy began, and was told that she was safe to continue whilst pregnant. The show will feature interviews with Prof Pilling, who will say that GP prescription guidelines are about to be updated to take into account evidence suggesting a link with SSRIs and heart defects.”

A manufacturer contacted by the BBC denies any link to major foetal malformations (no prizes for guessing Lundbeck here).

Panorama spoke to eight mothers who had babies born with serious heart defects after taking a commonly used SSRI (selective serotonin reuptake inhibitors) antidepressant while pregnant.

An article on BBC News stated “Lundbeck, the manufacturer of Citalopram, said a recent review of scientific literature concluded that the drug ‘does not appear to be associated with an increased risk of major foetal malformations’.”

It seems that Lundbeck are lying again or there is a serious lack of communication between the various medicines regulators and the pharmaceutical industry. Below is an adverse reaction report logged with the Irish Medicines Board involving a baby born with a Cleft Lip, associated with the mother’s use of Citalopram.

IMB 1

What about the following, also reported as Citalopram induced? This particular report concerns the intrauterine death of an unborn baby due to ‘Citalopram exposure during pregnancy’.

IMB 3

Then there was our meeting in Copenhagen with the two Lundbeck goons. We asked if Citalopram/Escitalopram was a teratogen. Their answers (or non-answers) may surprise you…

Leonie                       Right, will I go on because there’s no point, we’re stuck at that one?  Anyway.  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?

Leonie                       Yeah

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

Leonie                       So,

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?

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.

The Irish word ‘amadáin’ springs to mind. I could think of a few English ones too but think I’d better refrain. The Panorama programme should be excellent viewing as usual, particularly with Shelley Jofre as reporter. She did the previous expose concerning GSK and Seroxat suicides. I can see her putting Lundbeck in their place.

.

.

Lundbeck Meeting here.

IMB adverse reaction reports.

MHRA (UK) adverse reaction reports.

cipramil (celexa) stories,, lundbeck, Newspaper and internet articles

Are conflicting studies putting babies lives at risk?

Birth defects

How the same study with different conclusions could spell disaster for unborn and newborn babies.

Last year (2012) the BMJ published a study from 5 Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) based on more than 1.6 million infants born after gestational week 33 between 1996-2007.

This year (2013) JAMA published a report based on a study from all Nordic countries (Denmark, Finland, Iceland, Norway, and Sweden) at different periods from 1996 through 2007, also based on over 1.6 million births. So it’s a safe bet that the two studies are one.

Study Jan 2012. Here.

Study Jan 2013. Here.

The first study concluded that the risk of persistent pulmonary hypertension of the newborn doubled when the mother was using an SSRI.

This year the same study concluded that SSRIs do not increase the risk of infant deaths. Articles, like this one, which stated that “Recent research has cancelled the claims by saying that SSRIs do not pose any sort of risk” are at risk of wrongly giving the impression that these drugs are safe to take in pregnancy. Wrong! Stating that this is ‘recent research’ further gives the impression that this is a recent study, suggesting new findings. Also wrong!

The study was undertaken by a group of researchers from the Karolinska University Hospital, Stockholm, and initially warned that pregnant women who are taking SSRIs could be doubling the risk of having a baby with serious birth defects. This year though, the same researchers (bar one, Örjan Ericsson) presumably played with the stats, and concluded “Taking SSRIs during pregnancy do not up the risk of infant death.”

What the JAMA study actually found was that women who took an SSRI did have higher rates of stillbirth and infant death than those who did not. Although according to co-author Dr. Olof Stephansson, “this was because of an increased proportion of smokers, older [maternal] age, diabetes and hypertensive disease.” That’s not quite the same as saying ‘SSRIs do not pose any sort of risk’.

What the researchers failed to take into account is that SSRIs are in fact linked to increased rates of voluntary terminations. This may be because of the ‘disinhibition’ effect of SSRIs but more importantly, the findings could be due to Nordic women terminating pregnancies with significant birth defects. Similarly, in 2001 a woman wrote to GlaxoSmithKline, asking whether it was possible for her to have a healthy baby while using their drug Paxil (Seroxat). She had previously terminated her first pregnancy after discovering the baby had a serious heart defect (truncus arteriosus), and would likely not survive. Internal GSK documents were found to have stated that this baby’s heart defect was ‘almost certainly linked to Paxil’. Drug companies including GSK and Lundbeck have had no choice but to admit that Paxil and Celexa can have teratogenic effects, so it begs the question, why are these researchers putting babies lives at risk?

According to Professor David Healy, 1 in 10 pregnant Irish women are on antidepressants, leading to about 40 extra babies with significant birth defects and 200 extra miscarriages each year. So in the last 20 years, antidepressants have caused birth defects in 800 Irish babies and 4000 miscarriages.

That’s some discrepancy in the figures! Can any pregnant woman afford to take the risk?

https://leoniefennell.wordpress.com/2012/11/02/david-healy-v-veronica-o-keane-dr-adam-urato/

http://davidhealy.org/burn-in-hell/

Newspaper and internet articles, psychiatry, Random

Was Anna Byrne another Sertraline (Zoloft) victim?

There is a very public debate raging in Ireland at the moment regarding the tragic death of a young woman who died while suffering a miscarriage at Galway University Hospital. An estimated two thousand people protested outside Leinster House (Irish Parliment) in memory of Savita Halappanavar, who died of septicaemia as a consequence of the Irish Government’s reluctance/cowardice to legislate in this area. My heart goes out to her family and indeed to the woman and her child. The country is in uproar and rightly so.

There was another young woman who also died this year (March) but on this occasion there was no public outcry or no protest outside Leinster House (Irish Parliment). Anna Byrne was Carrying twins (almost full term) when she died by jumping off Howth head. Her inquest was held last week and was reported in the Irish independent (among other more sensationalist newspapers). Given the sensitivities surrounding this case and the fact that the family are (and will always be) grieving, I debated long and hard about writing about Anna. I was away with my family in Berlin when this report came out and Anna was never far from my thoughts; she and her two sons deserved more.

The really surprising thing was that the ‘Independent’ reported on the details of this unfortunate woman’s treatment. She was being treated by her doctor and subsequently a psychiatrist. Irish media, in cases where a person has died by suicide (unlike the UK and the US) rarely report on a person’s Inquest due to the fear of ‘copycat suicides’ and ‘social contagion’. There are strict media guidelines with the reporting of these cases; how’s that working in Ireland you might ask? Not too good!

Anna Byrne who was 35 and heavily pregnant with twins, had been on Seroxat for a number of years. This drug was discontinued earlier in her pregnancy. She was then put on Sertraline by her GP who described it as a commonly used antidepressant during pregnancy; seriously? Sertraline aka Lustral (Ireland) and Zoloft (US) commonly prescribed during pregnancy? Did this doctor not know of the birth defects associated with this family of drugs? Was this woman warned that this drug can cause suicide, depression, aggression, manic behaviour and serious birth defects? Adam Urato, assistant professor of maternal-fetal medicine at Tufts University School of Medicine and a co-author of a recent paper on this very issue, said:

“The truth of the matter is that we are currently witnessing a large-scale human experiment. Never before in human history have we chemically altered human foetal development on such a large scale… As I am telling you this right now, there is a doctor somewhere in the world counselling a pregnant woman that if she stays on her antidepressant medication she will help control her mood and that will lead to a better pregnancy result – and there really is not a shred of evidence to support that.”

Was Anna told that these drugs can, at the very least, double the suicide risk? Was she told that the  danger period is upon starting, discontinuing, or changing dosage (up or down)? This woman’s dose was doubled 6 days before her death by psychiatrist John Sheehan. C’mon, join the dots here. Does this woman and her two children not deserve every woman in this country to protest outside government buildings?

I looked up the psychiatrist ‘Dr John Sheehan’ and found him here, speaking at a conference supported by Pfizer (makers of Sertraline/Zoloft), Eli Lilly and Jansen. The speakers also included Timothy Dinan of UCC who last year denied any knowledge that Zoloft can cause suicide following Nicolas Maguire’s inquest in May 2011. Mr Maguire died by suicide shortly after being prescribed Zoloft for anxiety. Similar to most psychiatrists and medical professionals who publicly deny problems with these drugs, Timothy does a lot of work for pharmaceutical companies. This, unlike in the US, is not seen as a serious conflict of interest.

The body entrusted with the expertise in this area ‘The Irish College of Psychiatry’ (who have collectively denied that antidepressants can cause suicide) will defend their ‘medical model/drugs’ till the end, as in the recent debate with Professor Healy and Professor Veronica O’ Keane here. They will spout that the ‘benefits outweigh the risks’ till they actually convince themselves. This is despite the EMA warnings and despite the fact that the drug companies have admitted that the drugs can cause suicide. Notice the difference in Zoloft’s Patient Information Leaflet from Ireland and the US; Criminal.

I would remind medical professions that they are walking on thin ice, as was shown in the the case of Dunne (an inf.) v. National Maternity Hospital [1989] IR 91. Here it was found:

“A medical practitioner who establishes that he followed a practice which was general and approved by his colleagues of similar specialisation and skill is nevertheless negligent if the plaintiff thereupon establishes that such practice has inherent defects which ought to be obvious to any person giving the matter due consideration.”

Given that ex-Seroxat users have declared that the adverse discontuation effects can last for months and sometimes years, the introduction of Sertraline and the subsequent doubling of dosage can all cause a person to act on suicide ideation, it is entirely plausible that the medication caused Anna and her babies’ deaths. Considering Anna is dead, the benefits did not outweigh the risks in this case.

Where is the public outcry for Anna and her babies? The Irish Government have been informed by Professor David Healy that these drugs are causing suicide, that these drugs are the leading cause of death within the mental health field and that the same drugs are causing misciarrages and birth defects. At the same meeting Dr Declan Gilsenan said he had serious concerns that more people are taking their own lives as a direct result of seeking help (and subsequently prescribed mind altering drugs), than those who have not. The Government’s inaction on this issue is a bloody disgrace!

…………………………….

UPDATE REGARDING SEROXAT; Syracuse, N.Y. — Joe Mazella, Basketball coach, died by suicide in Sept 09 while on Seroxat. His widow, Janice Mazella has just won a $1.6 million medical malpractice verdict on Tuesday Nov. 20, 2012 against two psychiatrists who had treated the coach before he committed suicide. Here.

https://leoniefennell.wordpress.com/2012/05/03/the-medical-experts-meet-in-leinster-house/

http://www.theaustralian.com.au/news/world/new-drug-fears-for-pregnant-women/story-fnb64oi6-1226503730380

cipramil (celexa) stories,, Newspaper and internet articles, psychiatry, Random

David Healy v Veronica O’ Keane

Prof Healy

Last week Professor Healy spoke on RTE radio with Professor Veronica O’ Keane, consultant psychiatrist in Trinity College. The debate (podcast) centered on the ‘increased use of sedatives and antidepressants‘.

Professor O’ Keane stated that antidepressants are not addictive drugs, where-as Professor Healy said that they are indeed highly addictive and that it’s easier to come off benzodiazepines than antidepressants. Professor O’ Keane was ‘astonished’ at this ‘claim’ and gave a little snigger to show how absurd she thought this claim was.

Speaking on the long term use of antidepressants she said “Depression is not a condition that goes away; it’s a recurring condition and if people stop taking their antidepressants with this recurring condition, their chances of killing themselves are increased by two.” Professor Healy stated that it’s actually the drugs which increase the risk of suicide and violence and that “antidepressants come with ‘black box’ warnings in the US saying that they cause suicide.”

Professor O’ Keane then went on to say that “the black box warning that David is referring to is for under 24; there is no such warning for individuals over the age of 24 and in fact it reduces suicidal ideation in those over 65”. No mention of the black-box warning in this article where she states “Anti-depressants work in young people, in terms of alleviating suicidal ideation secondary to depression.” In the radio interview, she further went on to say “It’s very important that the public are aware, that the problem here is not antidepressants, the problem here is depression. Depression is the real killer.” Ah yes, it’s the person and not the drug.

Prof O’ Keane

Professor O’ Keane has been described as an ‘expert on mental health during pregnancy’. She stated here that “There is an idea that depressed women should struggle through pregnancy without help, and stay ‘pure… But depression is a physical disorder and should be treated.” In a paper published in the British Medical Journal by O’ Keane et al, here, the study concluded that Untreated depression in pregnancy is associated with poorer maternal health practices and less favourable obstetric outcomes. 

A letter regarding this paper was later published by the British Medical Journal, written by Adam C Urato, an attending Physician (Maternal-Fetal Medicine) at Tufts University, Boston. Dr Urato made some interesting points:

(1) I have several concerns regarding the recent “Pregnancy Plus” article entitled “Depression during pregnancy” by Veronica O’Keane and Michael Marsh. I am concerned with the content of the piece as well as the lack of transparency regarding the financial associations of Dr. O’Keane.

Dr Urato

(2) In the introduction to the piece, the authors comment: “The case presented here highlights many of the key issues involved in the management of pregnant woman with depression, particularly the importance of active treatment.” Depression during pregnancy is a difficult issue and one that I deal with on a regular basis as a practicing perinatologist. Depression during pregnancy is very concerning, as is the use of antidepressants during pregnancy. Active treatment is usually with a selective serotonin reuptake inhibitor (SSRI) and there is much to be worried about with maternal and fetal exposure to these drugs. Antidepressants have not been shown to improve maternal or child health outcomes during pregnancy. And in various studies antidepressant use in pregnancy has been associated with increased rates of spontaneous abortion, congenital malformations, preterm birth, low birthweight, fetal death, seizures, neonatal withdrawal syndrome, persistent pulmonary hypertension of the newborn and a possible predisposition to psychopathology.

(3) The question many readers might have after reading a piece that emphasizes the importance of antidepressant medication use in pregnancy is whether Dr. O’Keane is being paid by the antidepressant makers.

Professor O’ Keane has in fact listed her ‘Conflict of Interest’ as being with Eli-Lilly, creators of Prozac and Duloxetine (Cymbalta); Here. In another Article here, she said Prozac belonged to a family of compounds which represents ” one of the few major breakthroughs in the treatment of psychiatric illness in the past 40 years.”

Interestingly, numerous articles have been published this week regarding the dangers of antidepressants in pregnancy, including this one in the Irish Independent. This article quotes the same Dr Adam Urato: “Doctors are putting thousands of pregnant women and their unborn children at serious risk of harm by prescribing them anti-depressants, senior doctors are warning. Senior doctors say that ‘study after study’ shows the most widely used class of anti-depressant, called selective seratonin reuptake inhibitors, or SSRIs, cause pregnancy complications including premature birth and pre-eclampsia, which can both be fatal. Emerging research also suggests SSRIs can double the rate of autism in children, and increase the risk of lung and bowel diseases. The situation amounts to ‘a large scale human experiment’, according to Dr Adam Urato, assistant professor of maternal-fetal medicine at Tufts University, School of Medicine, Boston.”

So, who’s right and who’s wrong? I know who I’d believe. Professor Healy has coincidentally been saying for years that antidepressants can cause terrible birth defects in children “…even as the evidence accumulates that these drugs cause birth defects, double the rate of miscarriages, and cause mental handicap in children born to mothers who have been taking them.”

Considering Professor O’ Keane works in Trinity, the same College that Shane attended, it wouldn’t take much out of her day to speak to Shane’s lecturers. It would be interesting to hear her views on my son, who was loved and respected by his lecturers and who was known by them as ‘An Chroí mór’ (the big heart). Yet after 17 days on Cipramil, he killed himself and another. Maybe she’s so sure of her own opinion, that she doesn’t need to listen to us mere parents!

cipramil (celexa) stories,, lundbeck, Newspaper and internet articles, Random

The Teratogenic effect of SSRI’s including Citalopram.

Back to the problem of depressants/antidepressants in pregnancy…

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

 Leonie   So,

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.

Newspaper and internet articles

Newborn infants face doubled risk with SSRIs

Newborn infants face doubled risk with SSRIs

 
 
 
 
January 26, 2012 By Mary Anne Kenny Leave a Comment

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Infants born to mothers who take SSRIs during face more than twice the risk of pulmonary hypertension compared with unexposed infants, research has found.

Scandinavian data on 1.6 million infants showed 0.3 per cent of those exposed to an SSRI in late pregnancy developed persistent pulmonary hypertension, compared with 0.12 per cent of those never exposed. Newborns exposed to an SSRI only in early pregnancy had a less marked, but still significant, increased risk, with 0.19 per cent experiencing persistent pulmonary hypertension, the study found.

The authors said persistent pulmonary hypertension of the newborn was a rare disease, with an absolute risk as low as 1-2 per 1,000 infants in the general population.

“However, as the risk in association with treatment in late pregnancy seems to be more than doubled, we recommend caution when treating pregnant women with SSRIs,” they wrote in the BMJ.

“It is essential to plan the treatment and to weigh the risks of persistent pulmonary hypertension of the newborn when treating women in late pregnancy with those of relapse of depression and neonatal abstinence syndrome if therapy is interrupted.”

The study included data on 11,014 mothers who had filled a prescription for an SSRI during late pregnancy, and 17,053 who filled one during early pregnancy only. Mothers taking SSRIs were generally older and more likely to be smokers than those not on SSRIs.

GSK’s response to a consumer who had previously lost a baby to Paxil/Seroxat…http://davidhealy.org/burn-in-hell