FDA Panel Discusses Safety Of SSRI Use During Pregnancy

The New York Times (7/21, Barry ) reports, “Over nearly four decades since Prozac [fluoxetine] was approved for the treatment of depression, waves of concern about the effects of antidepressants during pregnancy have resulted in a practical consensus: Though use of the drugs may be associated with a slight rise in the odds of birth defects, the risk of leaving a mother’s depression untreated is often greater.” Now, among a “select group of experts convened by the Food and Drug Administration on Monday to discuss the safety of antidepressants during pregnancy, around half said that women should receive a more clear and forceful warning about potential risks to the fetus.” HHS spokesperson Andrew Nixon “said the agency would not comment on whether there were plans to require a so-called black box warning about the use of selective serotonin reuptake inhibitors, or SSRIs, in pregnancy.”

MedPage Today (7/21, Monaco ) reports, “Women should be better informed about the potential risks of using selective serotonin reuptake inhibitors (SSRIs) during pregnancy, and these risks should be weighed against their benefits, most speakers on an FDA panel selected by Commissioner Marty Makary, MD, MPH, agreed on Monday.” Makary said, “Up to 5% of women in pregnancy are on an antidepressant. Antidepressants like SSRIs can be an effective treatment for depression.” However, “he warned that SSRIs ‘may be unique’ because of their potential interaction with pregnancy.”

NBC News (7/21, Bendix ) also reports.

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Posted in In The News.