FDA Approves First Pill for Postpartum Depression

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FDA Approves First Pill for Postpartum Depression
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The FDA has approved the first oral drug for postpartum depression, a condition that affects an estimated one in seven mothers in the United States.

American Journal of Psychiatry

, which showed that the drug led to significantly improved depressive symptoms at 15 days, compared with a placebo group. Improvements were seen on day 3, the earliest assessment, and were sustained at all visits during the treatment and follow-up period . Patients with anxiety who received the active drug showed improved symptoms, compared with patients who received a placebo.

The most common side events reported in the trial were sleepiness, drowsiness, and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal behavior were not seen. The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user's ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, the agency said that people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.

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