FDA warns pregnant woman away from Paxil, citing birth defect risk

By Elizabeth Rhein

Published on October 20, 2005

The latest warning about Paxil came after its maker, GlaxoSmithKline, sent letters to doctors, notifying them that it was adding an additional warning to the prescribing information to the drug.

The warning states that physicians should be extremely cautious when administering the antidepressant to expecting mothers, as preliminary studies showed an increased risk of birth defects. In affected infants born to mothers taking Paxil, the most common defect were congenital weaknesses or holes in the muscle between chambers in the heart.

GlaxoSmithKline was quick to note that the completed studies are not conclusive, and that further testing will need to be done to determine the cause of the increased defect rate.

Women who are pregnant or planning to become pregnant should consider the risks carefully and talk to their doctors before choosing to take Paxil or any other antidepressant.

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