The FDA announced that a new black-box warning has been added to the labeling for Depo-Provera Contraceptive Injection. The warning alerts prescribers that prolonged use may result in loss of bone density. Pfizer, the drug's manufacturer, has also issued a Dear Doctor letter with the same information, and the new information also appears in the patient information sheet.

The loss of bone density increases the longer the woman is on the drug and so the black box warning says that Depo Provera shouldn't be used as a long-term birth control method (for example, longer than two years) unless other methods aren't adequate. This bone density loss may not be completely reversible after discontinuation of the drug. This bone density loss may not be completely reversible after discontinuing the drug.

The "warnings" section of the label says that women with osteoporosis risk factors (e.g., metabolic bone disease, chronic alcohol or tobacco use, anorexia nervosa, a strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass, such as anticonvulsants or corticosteroids) should consider other birth control methods. Another high risk group is adolescent women. The label warns that it's not known whether Depo-Provera might reduce their peak bone mass and increase the risk of osteoporotic fractures later in life.

Source: FDA, 2005

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