Still no Ortho Evra recall from FDA despite group’s call for action
The Ortho Evra patch is still on the market more than one year after a leading consumer advocacy group called on the Food and Drug Administration to issue a recall for the birth control patch. The Public Citizen Health Research Group petitioned the FDA in May 2008 to issue an Ortho Evra recall, citing the increased risk of blood clots and other side effects that that could face women who are use the patch.
Because the Ortho Evra patch delivers about 60% more estrogen into the blood stream than birth control pills, women who use the patch are approximately twice as likely to develop blood clots, including deep vein thrombosis. These blood clots in the legs or other parts of the body could travel to the lungs, leading to a pulmonary embolism.
Although Ortho Evra is still on the market, many women have stopped using the birth control patch due to the risk of side effects they may face. Despite this fact, more than 2.7 million Ortho Evra prescriptions were filled in 2007 alone.
While the FDA has not yet issued a recall on Ortho Evra in response to Public Citizen’s petition, the agency has taken action following previous petitions from the group. In August 2006, Public Citizen petitioned the FDA to issue a black box warning to alert users of Levaquin and other antibiotics of a potential risk of ruptured tendons. The agency added warnings in July 2008 after Public Citizen filed a lawsuit against the FDA.
Similarly, Public Citizen petitioned the FDA to strengthen warnings about Botox that the toxin could spread from the injection site, causing potentially life threatening side effects. The FDA added a black box Botox warning in April 2009.