- Posts: 15777
- Joined: Thu Dec 22, 2005 3:51 am
Group Urges F.D.A. to Take Contraceptive Off Market
By THE ASSOCIATED PRESS
WASHINGTON (AP) â€” A consumer advocacy group petitioned the government Thursday to pull the birth control patch off the market, calling it far riskier than the pill.
â€œOrtho-Evra is a poor choice for women,â€ Dr. Sidney Wolfe of the group, Public Citizen, wrote the Food and Drug Administration.
Warnings about the Ortho-Evra weekly patch have escalated since a 2005 investigation by The Associated Press found that patch users had higher rates of life-threatening blood clots than did women who took birth control pills.
Blood clots are a rare side effect for estrogen-related products. Some studies of the risk suggest that patch users have twice the risk of clots in the legs and lungs as do women who swallow the pill because patients absorb up to 60 percent more estrogen with the patch. The Food and Drug Administration updated the patchâ€™s label in 2005, 2006 and earlier this year with clot warnings.
Demand has dropped, to 2.7 million prescriptions filled in 2007 from the 9.9 million filled in 2004, Dr. Wolfe wrote. But he argued that the patch offered no better contraception in return for the extra risk. And he said lawsuits by women who claim they were harmed by the patch had unearthed two previously unpublished studies from Johnson & Johnson researchers who found higher estrogen exposure from the patch even before it won federal approval in 2001.
A spokeswoman for the patchâ€™s maker, Ortho Womenâ€™s Health & Urology, a Johnson & Johnson company, said, â€œOrtho-Evra is a safe and effective hormonal birth control option when used according to its labeling.â€
The drug agency said it had not had an opportunity to review the petition.
Despite the risk, Dr. Wolfe said that abruptly cutting off users could result in unwanted pregnancies, so he urged the agency to phase out sales of the patch.