Ortho Evra Patch Facts

The Ortho Evra transdermal contraceptive patch was approved in November 2001 for the prevention of pregnancy. The FDA warned of possible problems with the Ortho Evra patch when it was first approved. The patch is considered dangerous to patients already at risk for adverse cardiovascular events such as heart attack, blood clots and stroke. It has also been shown to cause birth defects in children whose mother wore the patch while pregnant.

In July 2005, the Associated Press released a report of its study of more than 16,000 adverse events reported to the FDA by users of the Ortho Evra patch. Normal blood clot risk for women under 35 who use birth control pills but do not smoke is between 1 and 3 in 10,000. The risk of dying from such a clot for the same women, using the pill, is about 1 in 200,000. By contrast, the rate of nonfatal blood clots for women on the patch in the AP study was about 12 out of 10,000 users. The rate of deaths by blood clots while on the patch is about 3 in 200,000.

Ortho Evra has been linked to deaths among a dozen women from blood clots, most in their late teens and early 20s. Dozens more young women survived strokes and other clot-related problems, according to the reports.

Blood clots are considered an "accepted risk" from hormonal birth control because estrogen promotes blood coagulation. Clots usually form in the legs and can become serious problems if they travel to a woman's heart, lungs or brain.

The AP report described several of the deaths. One woman, a fashion student from Manhattan, collapsed and died in a subway station in New York City in April 2004. Another woman, Sasha Webber, 25 and a mother of two from Baychester, NY, died of a heart attack after just six weeks on the Ortho Evra patch. Kathleen Thoren, a 25-year old mother of three, died last fall after days of agonizing headaches. Admitted to intensive care because of pressure on her brain due to swelling, Ms. Thoren's coroner's report stated the swelling was due to hormones released into her system by the Ortho Evra patch.

Sources: "Risks seen with patch," Associated Press, July 17, 2005; Katrina Woznicki, "Birth Control Patch May Be Linked to Stroke Risk," MedPage Today, July 19, 2005.