General information: 

*          "The American Medical Association estimates that over 1% of pregnant women in the US, or more than 40,000, are taking antidepressants and sales of antidepressants in the US last year exceeded $12.5 billion.”

.

Armstrong, Wall St. Journal (Click HERE for full article)

 .

x

.

*  Paxil® crosses the placenta, which has important implications for the developing fetus. 

.

*  Serotonin (the neurotransmitter that Paxil® primarily affects) plays a role in fetal heart development.

.

FDA Public Health Advisories Concerning Paxil® Birth Defects:

.

December 2005 - FDA Link 

.

A study using a Swedish national registry found a 2-fold increased risk of having an infant with a cardiac defect compared to the entire national registry population. 

.

In another study in the US, women who received Paxil® in the first trimester of their pregnancies had a 1.5-fold increased risk of cardiac malformations, and over double the risk compared to other anti-depressant drugs.

March/April 2006 - FDA Link 

The FDA updated its data on Paxil® and the Risk of Birth Defects, explaining that early results of two studies "indicate that women who took Paxil® during the first three months of pregnancy were about 1.5 to 2 times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects)." The FDA advised "health care professionals not to prescribe Paxil® in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate."

July 19, 2006 - FDA Link

The FDA issued another Public Health Advisory titled "Treatment Challenges of Depression in Pregnancy."

Paxil® label re Pregnancy: 

In 2003, the prescribing information for Paxil® stated: "Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy."

The label also described GSK’s animal studies as having "revealed no evidence of teratogenic effects." ("Teratogen" means any substance with the potential to cause birth defects.) Paxil® was identified as a Category C drug (Category C drugs are those in which: "Either animal studies indicate a fetal risk and there are no controlled studies in women, or there are no available studies in women or animals.) The label also stated: "There are no adequate and well-controlled studies in pregnant women." The label further states that Paxil® "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." 

The FDA has changed Paxil’s® pregnancy category from C to D (Category D: "There is positive evidence of fetal risk, but there may be certain situations where the benefit might outweigh the risk (life-threatening or serious diseases where other drugs are ineffective or carry a greater risk). 

.

Anyone concerned about their taking Paxil or any other SSRI during pregnancy please call Board Certified lawyer, Rob Kwok, toll free:   1-888.JR.PAXIL for a free consultation.  [Top]

.