A dozen deaths linked to birth-control patch

Gingerly, Kathleen Thoren's family gathered around her in the intensive care unit, unable to speak to their beloved sister, daughter, wife, or even stroke her hands. The slightest stimulation might create a fatal amount of pressure on the 25-year-old woman's swollen brain, warned the doctors.

"We were horrified, but we tried to just quietly be with her," said her sister Erika Klein. "In the end, it didn't help."

The mother of three died last fall, just after Thanksgiving, after days of agonizing headaches that the coroner's report said were brought on by hormones released into her system by Ortho Evra, a birth control patch she had started using a few weeks earlier.

She was among about a dozen women, most in their late teens and early 20s, who died last year from blood clots believed to be related to the birth control patch. Dozens more survived strokes and other clot-related problems, according to federal drug safety reports obtained by The Associated Press under a Freedom of Information Act request.

Several lawsuits have already been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.

Though the Food and Drug Administration and patch-maker Ortho McNeil saw warning signs of possible problems with the patch well before it reached the market, both maintain that the patch is as safe as the pill.

However, the reports obtained by the AP appear to indicate that in 2004 — when 800,000 women were on the patch — the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.

The women who died were young and apparently at low risk for clots — women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station last April. Or Sasha Webber, a 25-year-old mother of two from Baychester, N.Y., who died of a heart attack after six weeks on the patch last March.

Some doctors, reviewing the Food and Drug Administration reports at the request of The AP, were alarmed. "I was shocked," said Dr. Alan DeCherney, editor-in-chief of Fertility and Sterility and a UCLA professor of obstetrics and gynecology.

But other doctors said they would have expected some deaths and no investigation is warranted. They point to more than 4 million women who have safely used the patch and note that the FDA reports are called in voluntarily, rather than gathered scientifically.