Warning
2005-132
November 28, 2005
For immediate release
Health Canada clarification on status of Evra contraceptive skin patch in Canada
OTTAWA - Health Canada is advising consumers that it is currently reviewing whether any product labelling changes are required for the Canadian version of the Ortho Evra contraceptive skin patch. It is important to note that the dosages and the manufacturing processes for the Canadian version are different than the patch approved in the United States.
Health Canada is taking this action in light of recent changes in the United States to product labelling information for the Evra patch.
Health Canada continues to monitor the safety of Evra through its post-marketing surveillance program. Once the review of the data is complete, Health Canada will quickly communicate any new safety information on this product to health care professionals and consumers, so they can make timely decisions on the risks and benefits.
On November 10, 2005, the U.S. Food and Drug Administration approved revised labelling for the Ortho Evra contraceptive skin patch that includes a new, bolded warning alerting health care providers that the amount of estrogen delivered through the skin produces a higher estrogen exposure than when taking the typical birth control pill. Greater exposure to estrogen may increase the risk of blood clots. The full Food and Drug Administration advisory is located at:
 www.fda.gov/bbs/topics/news/2005/NEW01262.html
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 physician.
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Media Inquiries:
Christopher Williams
Health Canada
(613) 946-4250
Public Inquiries:
(613) 957-2991
1-866 225-0709
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