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FDA Announces Important Labeling Changes for Mifepristone
BETHESDA, MD -- November 16, 2004 -- The Food and Drug Administration announced yesterday important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling.
The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all.
The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions. The label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies (tubal pregancies) as this condition may be missed by physicial examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy. Mifepristone is not effective for termination of these pregnancies.
For consumers, the Medication Guide states they should contact their health care provider right away for fever, abdominal pain, and heavy bleeding. Also, consumers are advised to take their Medication Guide to the emergency room or any health care provider they visit for problems. This allows health care providers to understand that the patient is undergoing a termination of pregnancy, and assess risks associated with that condition.
The revised labeling will provide physicians and patients with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion. FDA will continue to monitor the usage of Mifeprex and may take further action.
SOURCE: FDA
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