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GYN: Mifepristone WarningsFrom: art fougner, md (evsono@pipeline.com)Mon Dec 13 17:09:00 2004
>From ObGyn News ... Three Deaths Prompt New Warnings for Mifepristone FDA: No causation proved in any events. Timothy F. Kirn Sacramento Bureau In the wake of three deaths in women who had taken mifepristone to terminate an early pregnancy, the Food and Drug Administration has called on the manufacturer to strengthen the warnings in the drug's labeling, including the black box warning. The warnings about missed ectopic pregnancy, bleeding, and sepsis have been in the product literature already, but are going to be given more prominence, said Steven Galson, M.D., acting director for the Center for Drug Evaluation and Research at FDA, in a teleconference announcing the changes. The new, revised black box section of the prescribing information will take note of the fact that postmarketing surveillance has noted cases of infection and sepsis. The warnings section will now remind physicians that mifepristone (Mifeprex) is contraindicated in patients with confirmed or suspected ectopic pregnancy, and that ectopic pregnancy can be missed by ultrasound examination. The company that makes the drug, Danco Laboratories, will also be revising the medication guide handed out to patients with the medicine. The new guide will advise women to seek medical attention immediately if they have prolonged heavy bleeding (soaking through two thick, full-size sanitary pads per hour for 2 consecutive hours), or if they have severe abdominal pain or pelvic tenderness, or if they have a fever of 100.4° F lasting at least 4 hours. Since mifepristone was approved in 2000, the FDA has recorded 676 reports of adverse events in women who had taken the drug, including 7 cases of serious bacterial infection or sepsis, 17 ectopic pregnancies, and 72 cases of severe blood loss requiring transfusions. Two of the deaths were cases of sepsis and one was a ruptured ectopic pregnancy. The most recent death is a well- publicized case, because the family of the deceased California woman has begun pleading to have the drug taken off the market. The woman, who had just turned 18, died of sepsis in January 2004. FDA officials have said they did not learn about this death until August because the medical record mistakenly said the woman had take methotrexate—not mifepristone—to terminate her pregnancy. In announcing the changes to the labeling, Dr. Galson said the agency is not taking any other action at present, because no causation has been proved in any of the events, and he noted that no form of pregnancy termination is free of risk. He also said that no political pressure from inside the federal government influenced the FDA's action, nor is the new labeling designed to affect use of the drug, other than to make it safer. “We're really not in the business of discouraging or encouraging the use of any drug,” he said. Moreover, the labeling action is not tied to the petition submitted by antiabortion groups, including the American Association of Pro-Life Obstetricians and Gynecologists. The petition, which was submitted in August 2002, asks the FDA to withdraw approval of mifepristone. The agency is still considering its response, Dr. Galson said. Both sides in the debate over abortion weighed in immediately on this labeling action. Strengthening the warning admits implicitly that there is a problem with the drug, said Wendy Wright, senior policy director of Concerned Women for America, a group that is one of the signatories of the withdrawal petition. “Editing the warning box isn't enough to prevent further injuries and loss of life,” said David Stevens, M.D., executive director of the Christian Medical Association, also a petition signatory, in a press release. Planned Parenthood Federation of America said it supported the action because it ensures continued availability of a drug used safely by more than 1 million women nationwide. “Women and doctors nationwide report high levels of success and satisfaction with this early abortion option,” said Vanessa Cullins, M.D., vice president for medical affairs of Planned Parenthood, in a press release. Danco Laboratories is sending out a Dear Doctor letter to inform physicians, and specifically emergency department directors, about the changed label. The letter will enclose a textbook chapter about complications of induced surgical and medical abortions, so “emergency rooms will have a ready reference available,” FDA and company officials said. art
-- art fougner, md ich bin ein New Yorker
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