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Two pregnant women died and others were seriously sickened after taking the abortion drug RU-486 during the 21 months since its approval in 2000.

In an April letter to physicians, Danco Laboratories, the sole distributor of RU-486 in the United States, reported fatalities and illnesses associated with the "early option" abortion pill.

Congressman David Vitter, R-Louisiana, says these problems were expected, and he is holding the Food and Drug Administration responsible. "That letter is very stunning," Vitter told CT. "There are not proper patient protections in place. The longer [it] is tolerated, the more women's lives are put at risk." Vitter wants Congress to enact new restrictions on the use of RU-486.

The FDA approved RU-486 (also known as Mifepristone or Mifeprex) in September 2000 under an accelerated approval process previously used only for new drugs that fight life-threatening diseases or other serious illnesses. The FDA tested the drug in clinical trials on 859 women in the United States in 1994 and 1995.

Two powerful drugs are required to cause an abortion within the first 49 days of pregnancy. RU-486 blocks production of progesterone.

Doctors also administer Cytotec (misoprostol), a synthetic prostaglandin, approved for the treatment of peptic ulcers. Searle, the maker of Cytotec, warned physicians in an August 2000 letter not to give the drug to any pregnant woman.

But in April the FDA issued a revised label removing the blanket precaution against pregnant women using the drug. The new wording says the warning is intended only for pregnant women using the drug to treat stomach ulcers. The new label also warns about the risks of uterine rupture.

In the waning days of the Clinton administration, the FDA certified the abortion pill as "safe and effective" but declined to require restrictions that were in place during the trials (CT, June 11, 2001, p. 58). For example, the FDA initially considered requiring prescribing physicians to be qualified to read sonograms. An ultrasound examination can reveal the presence of an ectopic pregnancy, in which the fertilized egg implants outside the uterus, often in a fallopian tube. RU-486 is ineffective on an ectopic pregnancy.

An FDA official told The Washington Post that the agency worked with Danco on the April 19 letter sent to all doctors who have ordered the drug. The Danco letter notes "a small number of reports of ruptured ectopic pregnancies," including one that resulted in death. Danco also reports two cases of serious systemic bacterial infection, one fatal.

Meanwhile, a 21-year-old woman had a heart attack three days after taking ru-486. She recovered, according to Heather O'Neill, Danco's director of public affairs. Danco notes that these cases involved vaginal administration of drugs. FDA approval, however, is for oral use.

"I am skeptical that women having chemical abortions fully know the risks," says Gene Rudd, associate director of the Christian Medical and Dental Associations (CMDA).

The FDA says that it is "unknown whether there is a causal relationship between any of the events and the use of Mifeprex or misoprostol."

But Rudd says that the causal questions should be addressed through more careful research. The problems reported in the Danco letter, Rudd says, represent a "numerator without a denominator." He says health professionals need to know how frequently the drug regimen is prescribed.

"Every drug has problems," says Rudd, an obstetrician-gynecologist in Bristol, Tennessee. "Just having the case reports is not enough information to draw a conclusion."

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June 10 2002, Vol. 46, No. 7