Glaxo's Paxil Linked to Birth Defects

Glaxo's Paxil Linked to Birth Defects 09.27.2005, 05:55 PM

GlaxoSmithKline PLC warned doctors that its Paxil drug may be more closely linked to birth defects than other antidepressants, according to a letter published Tuesday on the Food and Drug Administration Web site.

The company said preliminary results from a retrospective analysis of women taking antidepressants during the first trimester of pregnancy found more birth defects associated with Paxil than other medications.
The infants' birth defects were typical of those in the general population, with the most common being holes in the walls that separate the heart's ventricles.

GlaxoSmithKline noted that the results conflict with another study and said it is changing the drug's label to reflect data from both trials.
The new label still states that there are not adequate and well-controlled studies in pregnant women.

The drug's label already stated that the drug can cause birth defects and that it should be taken during pregnancy only if the potential benefit outweighs the risk to the fetus.

The company said the conflicting data makes it hard to determine if Paxil actually causes birth defects and said it is continuing to study the issue.

The news came as a small group of protesters gathered at the company's U.S. headquarters in Philadelphia charging the company with being slow to publicize a link between suicide and the drug and calling for the company to pull Paxil from the market.