Antidepressant Safety Review Set For September

A U.S. advisory committee will meet in September to once again consider whether antidepressants raise the risk of suicide in children and teenagers, regulators announced on Monday. The Food and Drug Administration will present a new analysis of antidepressant data and ask the panel if more research or regulatory action is needed, according to a notice to be published in the Federal Register. FDA officials are trying to determine if widely used antidepressants such as Prozac make children or teenagers suicide-prone, or whether the disease itself is responsible. The advisory panel of outside experts considered preliminary data in February and urged stronger warnings to the public while the FDA probed further. In March, the agency urged close monitoring of antidepressant patients for signs of worsening depression or suicidal thoughts.

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