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The Food and Drug Administration (FDA) announced on November 17, 2004 that a black box warning is now required in the professional product labeling, or package insert, for the widely prescribed injectable long-term contraceptive medroxyprogesterone acetate (DEPO-PROVERA). This drug causes a significant loss of bone mineral density that may not be completely reversible. A loss of bone mineral density may increase a woman’s risk of fracture.
Medroxyprogesterone acetate is sold by Pfizer, Inc....
The Food and Drug Administration (FDA) announced on November 17, 2004 that a black box warning is now required in the professional product labeling, or package insert, for the widely prescribed injectable long-term contraceptive medroxyprogesterone acetate (DEPO-PROVERA). This drug causes a significant loss of bone mineral density that may not be completely reversible. A loss of bone mineral density may increase a woman’s risk of fracture.
Medroxyprogesterone acetate is sold by Pfizer, Inc. of New York. This drug was one of the most frequently used drugs in the U.S. in 2003. Almost 1.8 million prescriptions were dispensed.
A black box warning is the strongest type of warning that the FDA can require in a drug’s labeling. The Code of Federal Regulations requires a black box warning when special public health problems exist, particularly those that may lead to death or serious injury.
Unfortunately, the professional product labeling is not routinely distributed by pharmacists, and consumers usually never know if their drug has a black box warning. In the November 2000 issue of Worst Pills, Best Pills News, we published a list of 90 drugs with black box warnings.
The new warning also advises that medroxyprogesterone acetate should not be used as a long-term birth control method for longer than two years unless other birth control methods are inadequate.
The text of the new black box warning reads:
Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion [bone growth], will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. Depo-Provera Contraceptive Injection should be used as a long-term birth control method (e.g. longer than 2 years) only if other birth control methods are inadequate. |
What You Can Do
There is no reason that you should be using medroxyprogesterone acetate injection when there are numerous other methods of contraception available that do not cause a loss of bone mineral density.
