MDgonnabe

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from cnn.com:

FDA: Paxil Linked to Birth Defects


By Peggy Peck,
Managing Editor,
MedPage Today
December 08, 2005


ROCKVILLE, Md., Dec. 8-The FDA warned doctors today that preliminary results implicate the antidepressant Paxil (paroxetine) with an increased risk of birth defects.

The FDA informed doctors that results of new studies suggest that Paxil use during the first trimester increases the risk of congenital heart defects in the developing fetus.

The FDA advised physicians to discuss the potential risk of birth defects with women taking Paxil who plan to become pregnant or who are in the first trimester of pregnancy. Doctors should consider discontinuing Paxil in these patients and switching to another antidepressant if indicated. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus, the FDA said.

In general, however, the FDA advised that the drug should not be taken during pregnancy. But women who are taking Paxil should consult their physicians before stopping the drug. The FDA action was prompted by results of two studies that showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. The most common defects were atrial and ventricular septal defects that ranged in severity from minor, self-resolving defects to serious defects that required surgical repair.

The FDA said that in one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2%, compared with a 1% expected risk in the general population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5% compared to 1% risk for women taking other antidepressants.

The FDA said it asked Paxil's manufacturer, GlaxoSmithKline, to change the drug's label to upgrade the pregnancy warning from a category C to a category D, a higher level warning. The company changed the label two months ago to add data from one of the studies. The latest label change reflects data from both studies, the FDA said.
 

Anasazi23

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The increase in risk is quite small, but significant enough.

Particularly with Paxil and more commonly, serotonergic symptoms can be seen in infants after delivery. I've heard some psychiatrists talk about crushing and dissolving minute portions of tabs to wean the infant off.

Here's an FDA warning for Effexor.

Since we're on obstetrics, here is a case study showing safety in one patient receiving VNS while pregnant.
 

OldPsychDoc

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Anasazi23 said:
The increase in risk is quite small, but significant enough.

Particularly with Paxil and more commonly, serotonergic symptoms can be seen in infants after delivery. I've heard some psychiatrists talk about crushing and dissolving minute portions of tabs to wean the infant off.

Here's an FDA warning for Effexor.

Since we're on obstetrics, here is a case study showing safety in one patient receiving VNS while pregnant.
Just remember to weigh those risks against the risks of having a depressed mom who's not compliant with pre-natal care, etc...
 

Poety

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Hi all! I'm having a deja vu moment here - did I alreayd respond to this elsewhere? Anyway - I did a talk on this and they've actually found a significant impact on the infants when the mother took the ssri during hte 3rd trimester, its a big issue now in obgyn since its so critical to determine a womans risk for ppd prior to delivery to decrease or minimize her chances. There are some ob's that will treat immediately and are very effective at screening - however there are a lot that are still really hesitant to put a mom on anything in the last tri.

The patients I saw in ob were referred out for outpatient psych (^5 to the psych med student!) since I thought they psychs could better manage and decide the severity fo the depressiona nd risk for ppd :)

And back to the studies I read - it was something like 80% had significant withdrawal symptoms by week one post delivery - some ofcourse worse than others but paxil and effexor were bad - sorry I can't really rmember more!
 
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