Resources for Food and Drug Administration (FDA)

Birth Control Patch – A Threat for Women, FDA Pressed to Remove It

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 Ortho Evra as a contraceptive,” wrote Sidney Wolfe, head of the research group.

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