Advisory

2006-14
March 30, 2006
For immediate release

Health Canada update on status of Evra contraceptive skin patch in Canada

OTTAWA - Health Canada 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 Evra marketed in Canada is manufactured differently and contains less estrogen than the U.S. product.

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.

Blood clots are a relatively rare event but have been reported as a potential risk of all hormonal contraceptive therapy. Other serious side effects being examined in the studies include 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 labelling information on 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.

As with any medication, patients concerned about the risks and benefits of Evra should speak to their doctor.

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).

To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 866-234-2345
Facsimile: 866-678-6789

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney’s Pasture, AL 0701C
Ottawa, Ontario K1A 0K9

Email: cadrmp@hc-sc.gc.ca

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