Abortion Pill Under Scrutiny After Deaths

Six women who took the abortion pill mifepristone have become ill and two of them have died, although no direct link has been established between the medication and their illnesses, according to the manufacturer and the Food and Drug Administration.

Danco Laboratories of New York last week sent a letter about the cases to all doctors, clinics and hospitals that prescribe the pill, Mifeprex (formerly known as RU-486), which is given with the drug misoprostol. The letter, which the FDA posted on the Internet, reminded them to report any serious adverse effects such as death, hospitalization or blood transfusion.

Three of the women suffered ruptures of their ectopic pregnancies, which typically occur in the Fallopian tubes instead of the uterus. Such pregnancies, which make up about 2% of all pregnancies, should be carefully ruled out before prescribing the two-drug regimen, Danco reminded doctors. One of the three women died from excessive bleeding.

Two other women developed serious bacterial infections, one with a rare bacterium called Clostridium sordellii. That woman died, although neither the company nor the FDA believes that the drug regimen played a role in either case. Such body-wide infections have in the past been associated with menstruation, childbirth, miscarriage and abortion, but “we do not believe that Mifeprex and misoprostol present a special risk of infection,” the company wrote.

The sixth woman, a 21-year-old, suffered a heart attack but later recovered. FDA officials continue to review her case. Women who take the two-drug regimen first take mifepristone, which interferes with a fetus’ attachment to a woman’s body, followed by misoprostol to cause contractions. The contractions help expel the fetus.

The abortion pill was first used in France. Doctors there initially paired it with a different drug to cause contractions, but after that drug was associated with heart attacks, it was replaced with misoprostol. The latter drug hasn’t been linked to heart trouble.

Mifepristone hit the U.S. market 17 months ago, when the FDA approved its use within the first seven weeks of pregnancy; Danco began shipping it in November 2000.

Danco spokeswoman Heather O’Neill declined to say how many U.S. women have used it, adding that the information is proprietary. She characterized the six cases as “an extremely small incidence relative to the overall use.”

She warned women taking the drug that the biggest clue that something could be wrong “is the absence of response to the regimen.” Most users will begin to bleed and complete the pregnancy termination four to 24 hours after taking misoprostol; bleeding typically is heavier than a normal period.

According to an FDA official who spoke on condition of anonymity, the agency worked with the company to draft the letter advising doctors about the cases, but “there was no urgency on the part of the agency to think the Mifeprex was dangerous, or that any action needed to be urgently taken.”

According to “Mifepristone Questions and Answers” that the FDA posted on its Web site, the women who became ill received the misoprostol vaginally, instead of in pill form, and “the FDA has not reviewed data on the safety and effectiveness of vaginal administration of misoprostol.” The agency also said that it didn’t know “what role, if any, Mifeprex and ‘off-label’ use of vaginal misoprostol may have in developing serious infections.”

Abortion opponents said the safety alert highlights the dangers of nonsurgical abortions. “The FDA approved RU-486 under intense political pressure, and now women are suffering the consequences,” said Wendy Wright, senior political director of Concerned Women for America. “We warned the public that this would happen when the drug was approved. RU-486 is harmful to women.”

Supporters maintain that nonsurgical abortion with the pill is still a safer alternative to surgical abortion. “This remains a very safe and effective way to terminate an early pregnancy,” said Vicki Saporta, president and chief executive of the National Abortion Federation.