A Riskier Oral Contraceptive?

Feb 07, 05:00 AM

Current Headlines: By Rita Rubin

A consumer group petitioned the Food and Drug Administration Tuesday to ban oral contraceptives that contain the synthetic hormone desogestrel because studies suggest that, compared with other birth control pills, they nearly double the risk of potentially fatal blood clots without improving protection against pregnancy.

Public Citizen's petition says an estimated 7.5 million prescriptions for desogestrel-containing oral contraceptives were filled last year in the USA. Sidney Wolfe, director of the Public Citizen Health Research Group, says that represents one-sixth to one-fifth of all U.S. prescriptions for birth control pills.

Studies back to 1995 suggest that pills containing desogestrel cause 30 cases of blood clots for every 100,000 users a year, compared with 15 cases in 100,000 users of older pills a year, the petition says. Banning pills containing desogestrel could prevent hundreds of women every year from having blood clots, Wolfe says.

"The evidence just keeps accumulating," Wolfe says. "The FDA, I would have thought, might have done something about it."

On the pills' labels, under the heading "Risks of Taking Oral Contraceptives," a warning ("in barely perceptible 4-point type," Wolfe says) states that the blood-clot risk may be greater with desogestrel-containing pills than with other low-dose oral contraceptives.

Responding to Public Citizen, Barr Pharmaceuticals, maker of six of the 10 oral contraceptives cited, said in a statement: "The labeling that accompanies the company's oral contraceptive products provides all the necessary warnings and precautions for the appropriate use of the products."

A statement from Ortho-McNeil, whose Ortho-Cept also was cited, echoed Barr's: "When used as labeled, Ortho-Cept is a safe and effective birth control choice."

Older pills contain norgestrel, levonorgestrel or norethindrone instead of desogestrel. All four are progestins. Contraceptives containing desogestrel were developed in the 1980s in an effort to reduce adverse effects such as acne and excess hair, Public Citizen says.

The FDA's Susan Cruzan says the agency is reviewing the petition. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.