Birth control patch warning about blood clots - Evra contraceptive patch - Health Canada

Contraception :: Birth control patch warning about blood clots - Evra contraceptive patch - Health Canada

Janssen-Ortho Inc., in consultation with Health Canada, wishes to highlight important new safety information pertaining to Evra. The Evra transdermal system marketed in Canada contains 6.0 mg norelgestromin (NGMN) and 0.60 mg ethinyl estradiol (EE) and is approved for use in contraception (prevention of pregnancy).

Ortho Evra? is the formulation of Evra marketed in the United States and contains 6.0 mg NGMN and 0.75mg EE. Although Evra and Ortho Evra? are manufactured differently and therefore contain different total amounts of estrogen, the risk of side effects reported for Ortho Evra? is considered to apply equally to the Evra formulation available in Canada.

The results of a recent study indicate that women using the Ortho Evra contraceptive patch (the formulation of Evra marketed in the United States) had an increased risk of blood clots in the legs and lungs compared to women using an oral contraceptive. Another study indicated no difference in the risk of blood clots in the legs and lungs in women using Ortho Evra compared to women using an oral contraceptive.

Women who are obese are at particularly high risk of blood clots.

Due to a theoretical risk of unintentional increase in estrogen exposure from the patch, patients are recommended not to expose the patch area to sources of heat such as sauna or whirlpool bath.

The current Canadian labeling 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 of blood clots can include, but are not limited to, pain the calf, shortness of breath, chest pain or coughing blood. Patients concerned about the risks and benefits of Evra should speak to their physician.

Janssen-Ortho Inc. has provided this information to physicians, nurses and pharmacists across Canada.

The U.S. Food and Drug Administration issued a similar warning about Ortho Evra in late September.




(Contraception :: Birth control patch warning about blood clots - Evra contraceptive patch - Health Canada published at SpiritIndia on Friday, November 24, 2006)

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