GSK antidepressant Paxil to blame for baby's heart defects, US jury rules

[Christa]

A US family has been awarded $2.5 million (£1.6 million) in damages after a Philadelphia jury decided that the antidepressant Paxil, known as Seroxat in Britain, was responsible for their son's birth defects.

GlaxoSmithKline Plc, the British manufacturer of Seroxat, said it would appeal against the verdict in the case, which is the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil' s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

"The first win is always huge, especially when you get a jury saying the drug caused the injury," Sean Tracey, the family' s lawyer, said after the verdict.

The drug, approved for US use in 1992, generated about $942 million in sales last year, or 2.1 per cent of Glaxo's total revenue.

The company said in a statement: "While we sympathise with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition."

Glaxo American depositary receipts, each representing two ordinary shares, fell 9 cents to $39.69 at 4:02 pm in New York Stock Exchange composite trading, after dropping as much as 1.4 per cent when the verdict was announced. Glaxo dropped 14 pence, or 1.1 per cent, to 1,246.5 pence in London.

http://www.telegraph.co.uk/health/healthnews/6335822/GSK-antidepressant-Paxil-to-blame-for-babys-heart-defects-US-jury-rules.html


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ETA link

[Ilsa]

1. I feel badly for this child and his parents. But I can't help but wonder

why her doctor or GSK said taking the drug during pregnancy would be okay. Alot of women give up tougher habits and more important drugs during pregnancy. I don't blame the mother, but I can't help but wonder why the doctor in particular agreed to support her taking the med. I have alot of questions about this situation.

[Fire_Medic_Dave]

8. Did you just call a medication for depression a habit?

[Ilsa]

9. No. not at all. I take meds for depression, also, and it isn't a habit.

It is a physiological medical condition. But women have also avoided other drugs during pregnancy for worse psychiatric conditions due to them being teratogenic. And there are activities and foods that have to be avoided as well.

Unless the mother was suicidal, then maybe she should have been advised to wean off the Paxil until after delivery.

[Fire_Medic_Dave]

10. That would assume that the jury was correct in their conclusion...

that paxil did in fact cause the defect. Without knowing the exact history and without having seen the evidence, it's impossible for me to come to an informed conclusion about whether the Dr's advice was sound or whether the juries conclusion was just.

[Sgent]

11. Depends on the depression

If mom was suicidal, giving up an antidepressent would be a bad move. Possibly switching to something else might be better however.

[Chemisse]

12. Some people could just go off it for a while, just to be safe

But others really can't stop taking an antidepressant. For these women, it seems all they can do is pick the one that seems the least risky and hope for the best.

[Quantess]

13. Paxil has a reputation of having dreadful withdrawal effects,

lasting several months after reducing dosage or quitting. It is a judgment call whether there really are any "tougher habits" to quit.

Plus, the birth defects may have occurred in the first few weeks or months of pregnancy, which really doesn't give the mother much time to discontinue taking paxil to prevent birth defects.

[FreakinDJ]

2. self delet

[HuckleB]

3. Is there a study that shows that birth defects occur more frequently when mom's are taking Paxil?

If not, how did the jury come to this verdict?

[supernova]

4. That's what I'd like to know

What was the evidence used to draw that conclusion.

Now, SSRIs have been associated with suicidal thoughts in the very young... but birth defects?

Heart birth defects occur in 1 in 100,000 live births in the industrialized world, naturally. Is this baby part of a cohort of more cardiac defects in people who take SSRIs?

[HuckleB]

5. This piece indicates that there may have been studies.

Paxil is noted on the chart as "associated with fetal heart defects when taken during the first three months of pregnancy," with a recommendation to avoid it during pregnancy. Other listed SSRIs are not given the same warnings.

http://www.mayoclinic.com/health/antidepressants/DN00007

[HuckleB]

6. More On The General Issue

Pregnant Women Warned By FDA to Avoid Paxil:
http://www.washingtonpost.com/wp-dyn/content/article/2005/12/08/AR2005120802118.html

Which probably arose from this study:
http://www.cmaj.ca/cgi/content/full/173/11/1320

and then the converse:

New Study Does Not Find Link Between Paroxetine and Cardiovascular Defects:
http://www.womensmentalhealth.org/posts/new-study-does-not-find-link-between-paroxetine-and-cardiovascular-defects/

[boobooday]

7. What jumped out at me

The drug generated $942 million dollars last year, but that was only 2.1 percent of Glaxo's revenue.

Jeebus.