Several lawsuits have already been filed by families of women who died or suffered blood clots while using the Ortho Evra birth-control patch, and lawyers said more are planned.
Though the Food and Drug Administration and patch-maker Ortho-McNeil Pharmaceutical Inc. 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 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 patch 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 Associated Press, were alarmed. “I was shocked,” said Dr. Alan DeCherney, editor in chief of Fertility and Sterility and a University of California at Los Angeles 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.
“It doesn’t jump out at me to say, ‘Let’s look at this any further,’” said Dr. Steven J. Sondheimer, professor of obstetrics and gynecology at the University of Pennsylvania. “I don’t feel that these need to be looked at in any detail.”
Ortho-McNeil, a subsidiary of Johnson & Johnson, says none of the deaths can be directly attributed to the patch. “Although we are investigating each and every one of the reports that we get, we have not drawn any causal relationships to the medication,” said Dr. Katherine LaGuardia, Ortho-McNeil’s director of women’s health care.
Not one? “Right,” she said. “It’s difficult to reach a definitive answer, and privacy laws prevent us from investigating as thoroughly as we wish.”
Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation. But how many clots are too many?
Reports show that before the patch was approved, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill. 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.