Group Says Ortho-Evra Too Risky For Market

Published: May 9, 2008

WASHINGTON - A consumer advocacy group petitioned the government Thursday to pull the birth-control patch off the market, calling it far riskier than the pill.

"Ortho-Evra is a poor choice for women," Sidney Wolfe of 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 patch users suffer higher rates of blood clots than women who take birth-control pills.

Some studies of the risk suggest patch users have twice the risk of clots in the legs and lungs as do women who swallow the pill. The FDA updated Ortho-Evra's label in 2005, 2006 and this year with clot warnings.

Demand has dropped from about 9.9 million prescriptions filled in 2004 to 2.7 million filled in 2007, Wolfe wrote.

Wolfe argued that the patch offers no better contraception in return for the extra risk. And he said lawsuits by women who claim they were harmed by the patch have unearthed two previously unpublished studies from Johnson & Johnson that found higher estrogen exposure from the patch even before it won FDA approval in 2001.

A spokeswoman for patch maker Ortho Women's Health & Urology, a J&J company, said, "Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling."