Birth Control Patch Claims 23 Lives and Counting

NEW YORK, July 15, 2005 ( - Federal drug safety reports obtained by The Associated Press under a Freedom of Information Act request, “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.”

AP points out that the majority of the women were young and in otherwise good health and at low risk for blood clots - “women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station last April,” the AP relates. “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 who reviwed the Food and Drug Administration reports “were alarmed,” according to the report.“I was shocked,” said Dr. Alan DeCherney, editor-in-chief of Fertility and Sterility and a UCLA professor of obstetrics and gynecology.”

The patch’s manufacturer, Ortho McNeil, claimed that one death attributed to the patch should not be counted because it occurred in a woman who had undergone surgery. “But an FDA reviewer, using capital letters and underscoring his comments, took issue with Ortho McNeil,” the AP report continued.

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS,” the reviewer’s report warns. “The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases . . . The incidence rates quoted by the sponsor may be misleading.” The reviewer added, “The label should clearly reflect this reviewer’s safety concern about a potential increased risk.”

The AP reviewed 16,000 files related to patch-related effects. “These ranged from mild rashes to deaths, and there were many duplicate reports,” they said. “Within this collection of reports, the AP found 23 different deaths associated with the patch. The primary cause of death in those reports isn’t always clear—some mention suicide, others abortion. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from last year.”

See the AP report:


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