FDA has not heeded group’s petition for Ortho Evra recall
More than one year after the consumer advocacy group Public Citizen called on the Food and Drug Administration to issue a recall of the Ortho Evra birth control patch, the agency has yet to take any publicized action in response. Many women continue to use Ortho Evra—including about 2.7 million prescriptions as recently as 2007—despite the group’s call to withdraw the patch.
Public Citizen’s petition in May 2008 called on the FDA to remove the patch from the market within six months due to an increased risk of side effects compared with other birth control products. Because the Ortho Evra patch releases about 60% more estrogen into the bloodstream than birth control pills, women who use the patch are about twice as likely to experience serious blood clots as with the pill.
Although the FDA has heeded previous petitions from Public Citizen, it has sometimes taken them a year or long to take action. In August 2006, the group petitioned the FDA to issue a “black box” warning about the risk of tendon ruptures with Levaquin and other antibiotics, which the agency finally did almost two years later in July 2006.
Similarly, in January 2008, Public Citizen called for warnings about the risk of serious side effects from Botox, including potentially life-threatening swelling, breathing or swallowing problems. The FDA issued a black box warning about Botox in April 2009.