05/12/2008- The Ortho-Evra birth control patch is far riskier than the pill, a consumer advocacy group said. The group petitioned the government to remove the birth control patch from the market, as it represents a threat for women who use it.

An investigation lead by the Associated Press in 2005 found women who use birth control patch face a higher risk of potentially fatal blood clots than those who use other hormone-based contraceptives.

The FDA has updated the Johnson & Johnson drug's labeling three times to notify about the risks, including once early this year. In the petition to the FDA, the consumer advocacy group says that the Johnson and Johnson birth control patch is not an effective and safe method of contraception and it ignores the extra risk of blood clots. The amount of estrogen released from the Ortho Evra patch varies widely among individual women, it added. “The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of OrthoEvra as a contraceptive,” wrote Sidney Wolfe, head of the research group.

On the other hand, a spokeswoman for patch maker Ortho Women's Health & Urology, a J&J company, said, according to the AP, “Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling.”

“Hormonal birth control methods have benefits and risks,” she added. “The approved labeling has always stated the known risks associated with its use.”

A witness from inside the company said that he raised concerns over “dangerously high levels of estrogen” that women who used the patch were exposed to, but he was ignored.

The FDA has received several reports of life-threatening blood clots associated with the use of the birth control patch. Studies showed women using Ortho Evra were two times more likely to suffer a type of blood clot called venous thromboembolisms (VTEs), which may lead to a fatal pulmonary embolism, than those taking other birth control pills.birth control