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WASHINGTON (Reuters) - A U.S. advocacy group is urging the Food and Drug Administration to pull Johnson & Johnson's birth control patch from the market after studies found an increased risk of dangerous blood clots.
In a petition filed with the FDA on Thursday, Public Citizen's Health Research Group said the amount of estrogen released from the Ortho-Evra patch varies widely among individual women, causing up to twice as many clots and other painful side effects.
"The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho-Evra as a contraceptive," wrote Sidney Wolfe, head of the research group.
Ortho-Evra has seen its use slip in the wake of such data, which led to warnings on the patch's label as recently as January, when a study of women ages 15 to 44 found blood clots known as venous thromboembolisms were about twice as likely in women using the patch versus birth control pills.
The FDA at the time said the patch was safe and effective when used as directed and urged patients to talk to their doctors about the risk.
Estrogen used in contraceptives has long been known to increase the risk of blood clots, which can trigger heart attacks or strokes. Women who use Ortho Evra are exposed to about 60 percent more estrogen than pill users.
"If Ortho-Evra had been designed as a pill, it is unlikely to have been approved because of its increased estrogen content," Wolfe said.
Still, about 2.7 million prescriptions were written for the patch last year, keeping it among the top 200 brand-name drugs sold in the United States, according to data cited by the petition. More than 9.9 million prescriptions were written in 2004.
The FDA has said the chance of developing a clot is low. For every 10,000 women who use hormonal contraceptives for one year, some three to five of them will develop a clot, the agency has said.
Ortho Women's Health & Urology, the J&J division that makes the contraceptive patch, has said its patch has risks and benefits like all hormonal contraceptives.
The company has marketed the patch as a more convenient alternative to daily birth control pills, which are less effective if a dose is missed.
Wolfe conceded that data showed patients do comply better with the patch, but added there was no difference in the number of patients who ended up pregnant.
