ROCKVILLE, D.C., Nov. 17 (UPI) -- The U.S. Food and Drug Administration Wednesday said a black box warning about bone density will be added to packaging of the contraceptive Depo-Provera.
This is one of the most serious of the FDA warnings, and it tells physicians and consumers the contraceptive injection, used for many years in the United States and overseas, may result in the loss of bone density -- a serious concern to women as they age.
The FDA and drug manufacturer Pfizer Inc. said while the drug is very safe, prolonged use could result in significant loss of bone density -- and the longer the medication is used, the worse the loss becomes -- which may not be entirely reversible.
The warning states a woman should use Depo-Provera as a long-term birth control method -- for example, longer than two years - only if other birth control methods are inadequate.
Pfizer also is sending letters to physicians about the bone density issue and will incorporate the warning in patient information sheets distributed with the injectable drug.
