Women using the Ortho Evra Patch have suffered complications, including 21 "life-threatening" cases of blood clots and other ailments, according to the Food and Drug Administration (FDA). The contraceptive patch, which has been aggressively marketed using Olympic athletes, sexy ads, and fashion models, has been linked to the deaths of at least 17 young American women over the past two years.
Doctors who reviewed the reports said they were alarmed at the number of fatalities. "This is a cause for concern," said Dr. John Quagliarello, a professor of obstetrics and gynecology at NYU Medical Center. As of the initial FDA announcement in 2005, approximately four million women had used the Ortho Evra Patch since it went on sale in 2002.
A subsequent study, including patient chart review, was conducted by a group of investigators (i3 Ingenix). Results of this case-control study show an approximate two-fold increase in the risk of medically verified VTE events in users of Ortho Evra, compared to users of norgestimate-containing oral contraceptives (“the pill”), which contain 35 micrograms of estrogen. Longer follow-up for VTE, heart attack and stroke, has been requested by FDA.
On September 20, 2006, FDA announced an update to the Ortho Evra label with the results of the above-mentioned epidemiology study, in addition to another study sponsored by Johnson and Johnson, that were designed to evaluate the risk of experiencing serious side effects (especially due to venous and arterial blood clots) when using Ortho Evra.
The first fatality publicly blamed on the patch came in April 2005, when a Manhattan fashion student who hoped to compete on the TV show "America's Next Top Model," collapsed in a Midtown subway station. An autopsy found a blood clot had moved to her lung, and the medical examiner ruled it a side effect of the birth-control device.
FDA records show that 17 patch users, ages 17 to 30, suffered fatal heart attacks, blood clots, and possible strokes since August 2002. Ortho-McNeil, who makes the patch, has paid supermodels like Naomi Campbell and the Norwegian Olympic beach volleyball players to promote the patch.
