Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Canadian pharmaceutical company Janssen-Ortho, Inc. in cooperation with Health Canada has issued a press release updating information on the average daily release rates of contraceptive hormones from the EVRA Transdermal Contraceptive System (patch) that is marketed in Canada and approved for use for the prevention of pregnancy. EVRA is bioequivalent to Ortho Evra, the birth control patch that is marketed in the United States.

EVRA’s product information now includes average daily release rates for norelgestromin (200 micrograms every 24 hours) and ethinyl estradiol (35 micrograms every 24 hours). This information replaces the previously labeled daily delivery rate of norelgestromin (150 micrograms every 24 hours) and ethinyl estradiol (20 micrograms every 24 hours). The term “release rate” has also replaced the prevous term “delivery rate” as a more descriptive term regarding release of hormones from the patch.

The new data was derived by measuring the hormone content that remained in the EVRA patches worn by women for 7 days. The previously labeled delivery rate information was estimated using a different method. The company reports that there has been no change to the way the patch is made, and there is no known impact on the safety and effectiveness of the patch as a result of the new information on the average daily release rate.

In November 2006, Health Canada issued a letter to health care professionals warning of the risk of venous thromboembolism in users of Ortho Evra and expressed that the same warning should apply to EVRA. Studies have found that the patches can leak too much medicine into the blood stream, causing blood clots that can lead to strokes and even death.

To date, more than 500 lawsuits have been filed on behalf of women who suffered blood clots and other serious side effects from taking Ortho Evra. Recently, drug maker Johnson & Johnson settled lawsuits with Canadian women harmed by the birth control patch.

Sources:

Janssen-Ortho, Inc.
Health Canada

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