FDA approves brain tumor warning on Depo-Provera label as court battle grows over side effects
The U.S. Food and Drug Administration has approved a change 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.
The regulatory 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.
But the lawsuits argue 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 “duty to investigate the foreseeable potential” that the shot could cause cases of meningioma.
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