Ortho Evra
November 23, 2006Ortho Evra birth control patch side effects spur Health Canada warning
Two months after the U.S. Food and Drug Administration issued a warning about Ortho Evra birth control patch side effects, the Canadian health agency is following suit. Health Canada has warned women north of the border that use of the birth control patch may increase their risk of developing blood clots in the legs and lungs.
The agency issued its statement based on research that showed a U.S. formulation of the company’s contraceptive patch may be associated with a higher risk of blood clots compared with birth control pills.
Health Canada also warned women about wearing the Ortho Evra patch in hot tubs or saunas. Previous studies have reported that because of the increased temperature in these environments, wearers can receive a much higher dose of estrogen than they would under normal temperatures. This can increase a patient’s risk of experiencing birth control patch side effects.
Health Canada spokesperson Alastair Sinclair says, “We’re taking the precaution of giving people an additional heads-up that there’s a risk of blood clots with the product.”
Janssen-Ortho’s U.S. formulation features the brand name Ortho Evra. Although the Canadian product (sold as Evra) has less estrogen, Health Canada contends that both products carry the same risk of adverse events.
Obese women are at an even higher risk of Evra birth control patch side effects. And some experts feel that heat can lead to increased exposure of estrogen, so women wearing the Evra patch should avoid saunas, whirlpool baths, hot tubs and anything that might increase body heat.
According to Sinclair, 78 adverse events have been reported by Canadian users of Evra since the patch went on the market in early 2004. Fourteen of those cases involved blood clots, and one was a heart attack.
The FDA issued a similar warning about Ortho Evra two months ago.