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Paxil: Stronger Birth Defects Warning

Heart-Related Birth Defects Noted in 2 Studies; Cause Not Clear
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Studies' Results

According to the FDA, early results from the two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 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.

In one study, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2%, compared with a 1% risk in the whole 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 with 1% in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

Weighing Risks and Benefits

The FDA's news release notes that "the benefits of therapy may outweigh the potential risks to the fetus." "In the labeling, I think there's some important guidance for prescribers as well as patients to take note of," Renegar says.

"The labeling now advises that patients who become pregnant while they're taking [Paxil] should certainly be informed of the potential harm to the fetus," she says.

"Consideration should be given to discontinuing [Paxil] or perhaps switching to another antidepressant, unless the benefit that the mother is experiencing justifies continuing treatment," Renegar continues.

"For women who intend to become pregnant or are in their first trimester of pregnancy, other treatments and options should be considered first before initiating Paxil. So these are the recommendations that GSK and the FDA support to help put this information in a useful context for physicians as well as women to make well-informed treatment decisions," she says.

Maker's Comment

"These studies that are referenced in the new labeling are largely updated analyses from the data that was the justification for the change in September," Renegar says.

"We have worked very closely with the FDA on the data interpretation, and what the labeling should say, and how to most quickly and effectively get this out into the public," she says. "It was a collaborative effort."

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