Archive for Sunday, July 17, 2005

Reports show more fatalities than expected from birth control patch

July 17, 2005

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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 Admin. 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.

Some doctors, reviewing the FDA 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.

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 younger than 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.

Dr. Philip Darney, a professor of obstetrics and gynecology at the University of California, San Francisco, and a leading contraceptive researcher, cautioned that the FDA's adverse event reports tend to be inflated for newer products like the patch.

Patients and doctors are more likely to contact the FDA when they have a bad reaction to a new drug than for something that has been on the market for a long time, he said. In addition, women using the patch are likely to either be new to hormonal birth control or have reacted poorly to the pill and are looking for a change. The result is that the pool of women using the patch are at higher risk than birth control users at large.

He tells patients, "If you can use a pill safely, you can use a patch safely, and we're going to know a lot more later as more women use patches," he said.

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