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BMD loss prompts black box for Depo-Provera.(Gynecology)
The U.S. Food and Drug Administration has added a black box warning to Depo-Provera to emphasize the potential for bone mineral density loss with long-term use of the injectable contraceptive.
Depo-Provera has been used throughout the world for decades and remains a safe and effective method of birth control, the FDA said in a statement. However, a recent review of the drug's long-term effects on bone mineral density (BMD) by the FDA and Pfizer Inc., which manufactures the drug, prompted the addition to the label.
The black box warning notes that women who use Depo-Provera may experience a significant decrease in BMD that might not be completely reversible after discontinuing use. Consequently, Depo-Provera should be used as a long-term birth control method (more than 2 years) only if other methods are inadequate.
The warning also states that it's not known whether Depo-Provera use during adolescence or early adulthood will reduce peak bone mass and increase the risk of osteoporotic fracture in later life.
Since the U.S. approval of Depo-Provera in 1992, the ...
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Source: HighBeam Research, BMD loss prompts black box for Depo-Provera.(Gynecology)