Feds Strengthen Warnings on Abortion Drug

November 16, 2004
Federal regulators are strengthening health warnings on the "morning-after" drug RU486, following the third death since the drug was approved in 2000.

A California woman died in January after a bacterial infection in her uterus spread to her blood, leading to sepsis, or blood poisoning, Lester Crawford, the Food and Drug Administration's acting commissioner, said.

The new warnings remind physicians to watch their patients carefully for signs of systemic bacterial infection, excessive vaginal bleeding and ectopic, or tubal, pregnancies.

Anti-abortion advocates say that the latest death demonstrates that RU486, also known as mifepristone, is unsafe and should be withdrawn from the market. Abortion rights advocates say that mifepristone has been used by nearly 360,000 women in the United States, and they argue that bad outcomes with the pill are exceptionally rare.

The latest death is similar to that of Holly Patterson, who died from sepsis after taking mifepristone Sept. 17, 2003, less than a month after her 18th birthday. Her father, Monty Patterson, became an outspoken critic of the pill.

Not everyone agrees RU486 is to blame for the latest death. Dr. Cynthia Summers, spokeswoman for Danco Laboratories, mifepristone's maker, said that she does not believe that the latest death should be attributed to mifepristone.

She said the coroner's report found that the California woman had taken methotrexate, a cancer drug that has also been used to induce abortions.

The drug already carries a black box label, identifying it as potentially dangerous. Now the FDA and the drug company have agreed to strengthen the warning, because of reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death.

The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information about these risks, including that death that may occur following any termination of pregnancy, including those terminated by RU486. While these risks are rare, the FDA says the new labeling and Medication Guide will provide the latest available information to all.

The new information also 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. The FDA said 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.

For consumers, the FDA 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 said it will continue to monitor the usage of Mifeprex/RU486 and may take further action.

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