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Consumer groups calls for Ortho Evra recall

May 9th, 2008

A leading consumer advocacy group has petitioned the Food and Drug Administration to issue an Ortho Evra recall, citing the increased risk of side effects that women may face by using the birth control patch. Public Citizen says that the risk of Ortho Evra side effects is much higher than with birth control pills.Concerns about the Ortho Evra patch escalated in 2005, when a study by the Associated Press found that women were more likely to suffer blood clots while using the patch than with birth control pills. Women who use the birth control patch receive a 60% higher dose of estrogen, which can increase the risk of blood clots and other Ortho Evra side effects. The FDA has since added three updates to the patch’s label to warn of the increased risk of blood clots.

Dr. Sidney Wolfe, the head of Public Citizen, says that the Ortho Evra patch is no more effective at preventing pregnancy than birth control pills. Dr. Wolfe says that Ortho Evra lawsuits filed by women who were injured after taking the birth control patch have uncovered two studies which show that the manufacturers of the Ortho Evra patch were aware of the increased estrogen dose that users face even before it was approved by the FDA in 2001.

In order to prevent unwanted pregnancies among women who stop using the patch, Dr. Wolfe is advising the FDA to gradually phase out sales of the patch over a six month period before the full Ortho Evra recall goes into effect. During this time, he proposes that women who are already using the birth control patch should only be allowed to get refills for their prescriptions. Dr. Wolfe says that this would give them time to switch to another birth control method.

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