Labeling changes for mifepristone

The FDA has announced safety-related changes to the labeling of Mifeprex (mifepristone), also known as RU-486, distributed by Danco Laboratories LLC of New York. The FDA and Danco have received reports of serious bacterial infection, including sepsis, severe bleeding, ectopic pregnancies, and death in women using mifepristone.

Sepsis is an overwhelming infection that has spread to the bloodstream. An ectopic pregnancy occurs when a fertilized egg develops outside of the uterus, usually in a fallopian tube, which can rupture and bleed if the pregnancy is not discovered early.

These reports led to the FDA's revision of the black box labeling on the product in November 2004. 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 pelvic 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, as this condition may be missed by physical 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 ectopic pregnancies.

The medication guide for consumers states that they should contact their health care provider immediately if they have severe abdominal pain or fever of 100.4 F or higher for four hours. These may be signs of an infection or ectopic pregnancy. Patients who soak through two full-size sanitary pads per hour for two consecutive hours also should contact their health care provider, as surgery may be needed to stop the bleeding.

Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less.