FDA reveals birth control Depo-Provera has long-term side effects

Thursday, December, 2, 2004; 12:29 PM | 0 | | Print

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Jenn Basham

Associate News Editor

The Food and Drug Administration recently added a black box warning to Depo-Provera, the popular injection contraceptive, after studies revealed that prolonged use of the drug causes a loss of bone density.

In a press release regarding the new warning, the drug manufacturer Pfizer explained: ?The revised labeling further notes that bone loss is greater with increasing duration of use and may not be completely reversible and that Depo-Provera should be used as a long-term birth control method (longer than two years) only if other birth control methods are ?inadequate?.?

Patients who receive the injections will be informed of the change as they receive the shot and through a letter from Pfizer.

When the drug appeared on the market in 1992, it listed the risk of developing osteoporosis as a side effect, said Darlene Taylor, spokesperson for Pfizer. After continued research showed a loss in bone density in women between the ages of 25 and 35, Pfizer finally decided to increase the warning.

Planned Parenthood still plans to offer the drug, with the recommendation that women limit their use of it to no more than two years, according to a statement by Susan Yudt on the organization?s website.

?This recommendation should not be a problem for most users because many women only use Depo-Provera for a year or less,? Yudt said.

There is some indication that once an adult woman terminates use of the drug the decrease in bone density is partially reversible, although doctors are not sure by how much. According to Pfizer, a study on the reversibility in bone density for adolescents is still underway.

?It is unknown whether or not there is complete recovery of bone mass or if temporary bone thinning leads to greater risk of bone fracture from osteoporosis much later in life,? Yudt said.

Pfizer has no doubts about the drug?s ability to stay on the market. Many women use Depo-Provera for its long term protection and privacy, Taylor said. ?It provides a continuous coverage if they?re travelling a lot, or if they need to be private about the contraceptive.?

The United States Agency for International Development and a number of women?s family planning groups have been excited about Depo-Provera because it gives women a certain freedom, Taylor said. They have been providing Depo-Provera in developing countries where women may not feel free to discuss birth control with their spouse.

The bone density risk in other progestin-only birth control methods is not as high because they do not release as much progestin as Depo-Provera, according to www.plannedparenthood.org. Other hormonal birth control methods including combination birth control pills, the patch and the ring contain protection against osteoporosis.

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