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Evra
Health Canada update on status of Evra contraceptive skin patch
2006-14
March 30, 2006
For immediate release
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 placecountry-regionCanada 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 placecountry-regionCanada issued a previous statement regarding Evra on November 28, 2005.
Warning
2005-132
November 28, 2005
For immediate release
Health Canada clarification on status of Evra contraceptive skin patch
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 placecountry-regionCanada 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 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.