Health Canada Issues Update on Status of Ortho Evra Contraceptive Patch

According to the latest Advisory from Health Canada, the agency “is currently reviewing the results of two studies looking at the risk of serious side effects when using the Ortho Evra contraceptive patch marketed in the United States.”

The version of Ortho Evra marketed in Canada is manufactured differently and contains less estrogen than the U.S. product that has been linked to a number of deaths in otherwise healthy young women.

Health Canada states that a “preliminary report on one of the studies shows an approximately two-fold increase in the risk of blood clots in users of Ortho Evra compared with users of an oral contraceptive. However, the second study concludes that the risk of non-fatal blood clots with the patch is similar to the risk of comparable oral contraceptives. Both studies, one of which is ongoing, were provided to Health Canada by Janssen-Ortho Inc., the manufacturer of Evra.”

The Canadian agency is also analyzing examining other serious side effects examined in the studies, including heart attack and stroke.

“Once the review is complete, Health Canada will communicate any new safety information on Evra to health care professionals and consumers so they can make timely decisions on the risks and benefits. Health Canada is continuing to monitor the safety of Evra through its surveillance program for drugs that are already on the market.”

The current Canadian labeling information on Ortho Evra contains a description of the risks and proper use of the product. There is also a detailed section on the importance of discontinuing the medication at the earliest sign of blood clots.

Common symptoms for blood clots can include, but are not limited to, pain in the calf, shortness of breath, chest pain, or coughing blood.

Health Canada issued a previous statement regarding Evra on November 28, 2005 (available at: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_132_e.html).

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