Health
Depo-Provera warning from FDA
NEWS IN BRIEF — Posted Dec. 13, 2004
The Food and Drug Administration has placed a "black box" warning on Depo-Provera contraceptive injection because of the risk of significant loss of bone density if the drug is used for a long time.
Bone density loss is greater the longer the drug is used, and the loss may not be completely reversible after the drug is discontinued, according to the FDA. Women should use Depo-Provera for longer than about two years only if no other birth control methods are adequate.
The warning information will also be distributed in a "Dear Health Care Practitioner" letter and in patient information that is distributed with the drug.
Although the drug has been available for years and remains a safe and effective contraceptive, according to the FDA, the agency and manufacturer Pfizer have taken the action to ensure that physicians and patients are aware of the information.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/12/13/hlbf1213.htm.
