Antidepressants to Come with Pregnancy Precaution

[CShine]

Drug makers are adding a notice to widely used antidepressants that babies of women who take the drugs late in pregnancy may experience jitteriness and other withdrawal symptoms, U.S. officials said on Wednesday. The Food and Drug Administration urged the precaution in light of scores of reports of withdrawal effects in newborns of women who took certain antidepressants during the third trimester of pregnancy, agency officials said.

The new information on drug labels urges physicians to carefully weigh benefits and risks of antidepressant therapy in women during the late stages of pregnancy, said Dr. Robert Levin, a medical reviewer in the FDA's division of neuropharmacological drug products.

Untreated depression poses serious risks for mother and baby, too, so doctors should not automatically avoid giving the drugs during pregnancy, FDA officials and members of an outside advisory panel emphasized. One option is to consider tapering off depression drugs 10 to 14 days before a mother's due date, Levin said.

Babies' withdrawal symptoms were reported after their mothers used drugs such as Prozac and Zoloft that are known as selective serotonin reuptake inhibitors, or SSRIs, as well as another antidepressant called Effexor made by Wyeth. Some of the most frequent withdrawal symptoms in infants included jitteriness, tremors, breathing difficulties, and trouble sleeping. Effects usually resolved on their own within days but in some cases required extended hospital stays, insertion of feeding tubes or other treatment. Long-term consequences are unknown, FDA officials and outside physicians said.

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