Serious bacterial infection may occur without the usual symptoms, such as fever and tenderness.

Holly Patterson died of septic shock caused by inflammation of the uterus days after taking mifepristone (trade name Mifeprex, also known as RU-486) to terminate an unplanned pregnancy, according to press accounts. She had visited an ER when adverse symptoms first developed but was sent home with pain killers.

The tragedy sparked controversy over the drug, manufactured by Danco Laboratories, with abortion opponents demanding that it be taken off the market and pro-choice advocates insisting that the pill was fundamentally safe.

Holly is the only American woman reported to have died following its use. However, the FDA's system of reporting adverse drug effects is voluntary. Holly's death originally was not reported by the hospital or by Planned Parenthood, which administered the RU-486, according to press reports.

A bill known as "Holly's Law," which would suspend FDA approval of RU-486, is making its way through Congress.

Risks Are Rare

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, the FDA says in a statement announcing the labeling change.

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, says FDA, the new labeling and Medication Guide will provide the latest available information to all.

Danger Signs May Not Be Present

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.

Take Info to ER

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, the statement concludes.