Ortho Evra Label Changed To Reflect Increased Risk Of Blood Clots

Jean Martin
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Posted by Jean MartinJanuary 24, 2008 1:40 PM

Yesterday the FDA approved changes to the Ortho Evra label that includes the results of a new epidemiology study that found that users of the Ortho Evra birth control patch were at higher risk of developing serious blood clots as compared to women who take birth control pills. This latest study, conducted on behalf of Ortho Evra manufacturer Johnson & Johnson, reiterates findings of two studies from 2006 which the company had attempted to downplay.

Ortho Evra is a patch that releases hormones through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills. Increased levels of estrogen increase the risk for forming blood clots.

It is important that women discuss with their physicians the risks and benefits involved with the different types of birth control methods available.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

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