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Drugs & Devices > Ortho Evra Patch

The FDA announced that it is launching a safety review of Ortho Evra birth control patches, following evidence that the patch is associated with increased side effects. The agency previously warned women in November 2005 that Ortho Evra was linked with higher incidences of blood clots.

The review is part of a larger probe to assess the safety of various patches. The agency is concerned that defects in the patches may lead to increased absorption rates, causing too much medication to be delivered to the patient. Evidence indicates women using the patch are exposed to approximately 60 percent more estrogen than those women using traditional birth control pills.

The FDA warned that women using the Ortho Evra birth control patch were at a higher risk for blood clots. The agency announced that the labeling on the medication will be updated to reflect this latest warning.

The warning noted that women using the patch are exposed to about 60 percent more estrogen than with a typical birth control pill. Higher doses of estrogen can lead to a higher risk of experiencing side effects.

The Associated Press reported that women using the Ortho Evra birth control patch were at a significantly greater risk of suffering a blood clot compared to women taking birth control pills.

The AP utilized the Freedom of Information Act to force the FDA to turn over reports of adverse drug reactions for Ortho Evra. The data demonstrated that women using the Ortho Evra patch were three times more likely to suffer a blood clot than those taking pills. The results are particularly alarming because these serious health problems are occurring in young, healthy women.

The FDA reports show that at least 17 women using Ortho Evra have died of blood clots since the patch was approved in November 2001. The actual number of women suffering fatal blood clots while using Ortho Evra patches may be significantly higher, as the FDA estimates it is notified on only a small percentage of adverse drug reactions that occur.

Ortho Evra was approved for use by the FDA in November 2001. The patch is available by prescription only and works by releasing hormones through the skin into the bloodstream to prevent pregnancy.

If you or a loved one has used Ortho Evra birth control patches, we encourage you to contact us

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