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GlaxoSmithKline's Seroxat gets heart defect warning

Date published: 09/12/2005

The US Food and Drug Administration have said that the warning label on GlaxoSmithKline's anxiety and anti-depressant drug Seroxat (marketed as Paxil in the US) is to be revised following evidence it can lead to birth defects.

The early results of two studies showed that women who took Seroxat 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.

Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart. The agency said that, in general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

The FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Seroxat, "the benefits of continuing may be greater than the potential risk to the fetus".

The FDA has asked GlaxoSmithKline to change the pregnancy category from C to D, a stronger warning. The warning category is used by doctors to decide whether or not to prescribe a specific drug to a woman who is pregnant.

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