STAT+: FDA approves brain tumor warning on Depo-Provera label as court battle grows over side effects
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The Food and Drug Administration has approved a change<\/a> to the labeling for a Pfizer birth control shot that warns patients of the risk of meningioma, a tumor in the layers of tissue that cover the brain and spinal cord.<\/p>\n The move comes as Pfizer is locked in a high-profile court battle with nearly 2,000 women, who claim the company knew for more than four decades about the cancer risk associated with long-term use of the quarterly injection but failed to warn patients. Depo-Provera was approved in 1992 by U.S. regulators.<\/p>\n But the lawsuits argue<\/a> that studies dating to 1983 have shown a link between meningioma and medroxyprogesterone acetate, which is the active ingredient in the product and a derivative of progesterone. The lawsuits maintain Pfizer had a \u201cduty to investigate the foreseeable potential\u201d that the shot could cause cases of meningioma.<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n