Before approval, the FDA noted nonfatal blood clots from the patch were three times that of the pill.
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.
Although 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. 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.
Ortho McNeil, a subsidiary of Johnson & amp; Johnson, says none of the deaths can be directly attributed to the patch.
Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation.
But how many clots are too many?
The AP found that before the patch was approved, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill. The AP then examined what has actually happened since the patch came on the market and found that deaths also appear to be at least three times as high.
If you are a woman taking the pill who doesn't smoke and is under 35, the chance that you are going to have a blood clot that doesn't kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is about 1 in 200,000.
By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.
Clots usually form in the legs and become serious problems if they travel to a woman's heart, lungs or brain.
In 2000, doctors at the FDA reviewing clinical trials of the wafer-thin, plastic patch warned that blood clots could be a problem if it was approved.
But when the patch was approved in the United States in 2001, there were no requirements for follow-up studies beyond routine FDA reviews of reports called in by consumers, doctors and manufacturers.
Some doctors who prescribe the patch warned that women should not overreact to news of deaths. It is more risky to remove the patch and become pregnant, several pointed out.
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