Black-Box Warning for Contraceptive Injection

The FDA has announced that a “black-box” warning will be added to the labeling of methoxyprogesterone acetate (Depo-Provera® Contraceptive Injection, Pfizer) because prolonged use of the product may result in the loss of bone mineral density.

Although this medication has been used for decades for birth control and is considered safe and effective, the FDA and Pfizer are taking this action to ensure that physicians and patients have access to this important information.
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The warning emphasizes that bone density loss increases with the length of usage and that the loss might not be completely reversible after discontinuation of the drug. Women should use the product for a long term (e.g., more than two years) only if other birth control methods have proved inadequate for them.