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'SEX PATCH' TIED TO 17 DEATHS: FDA

Jan 9, 2004 | New York Post

A trendy contraceptive patch which has been aggressively marketed using sexy ads, fashion models and Olympic athletes has been linked to the deaths of at least 17 young American women in the past two years, The Post has learned.

Scores of other women using the Ortho Evra patch have suffered complications, including 21 "life-threatening" cases of blood clots and other ailments, according to Food and Drug Administration reports obtained by The Post.

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.

He and other doctors said The Post's discovery was the first they've heard of multiple deaths linked to the popular device, which the manufac turer claims has been used by 4 mil lion American women since it went on sale in 2002.

The first fatality publicly blamed on the patch came this past April 2, when Zakiya Kennedy, 18, a Manhattan fashion student who hoped to compete on the TV show "America's Next Top Model," collapsed in a Mid town subway station.

An autopsy found a blood clot had moved to her lung, and the medical ex aminer ruled it a side ef fect of the birth-control device.

Zakiya's grand mother, Roberta Al loway, was shocked to learn that so many other young women using the device have also dropped dead.

"My grand daughter was an A student her life was cut short because she wore a patch to protect herself from getting pregnant," she said.

Ortho Evra — the only contraceptive patch on the market — delivers pregnancy-blocking hormones into the bloodstream. The patch is pitched as more convenient than the daily Pill, because it has to be changed just once a week.

Commercials show attractive young women calling the patch "birth control that's on your body, and off your mind." A voice-over warns that, like The Pill, "serious side effects include blood clots, stroke and heart attack."

FDA records, obtained by The Post under the Freedom of Information law, show that 17 patch users, ages 17 to 30, suffered fatal heart attacks, blood clots, and possible strokes since August 2002.

Ortho-McNeil has paid supermodels like Naomi Campbell and the Norwegian Olympic beach volleyball players to promote the patch.

An FDA spokesman said the agency discusses such reports only with the drugmaker, but reviews them for possible actions ranging from requiring stronger warnings to removing the product from the market.

Ortho-McNeil said the illnesses and deaths are "consistent with the health risks" of The Pill, which it says kills 0.3 to 1.9 women in every 100,000 users ages 15 to 29. Smoking dramatically raises the risk.

About 18 million Americans use The Pill each year.

"We've received six reports of fatalities in which the role of our product is unclear. We are continuing to investigate those reports," spokeswoman Mona Terrell said. She would not elaborate on those cases or the FDA reports.


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