2 more women die after taking RU-486

FDA issues alert against certain uses of abortion pill

March 18, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- Two more women who took the abortion pill RU-486 have died, according to federal drug regulators who are investigating whether the same rare infection that caused four earlier deaths was responsible.

In announcing the two additional cases yesterday, the Food and Drug Administration issued an alert urging doctors and patients to follow approved directions for the drug, which is used in combination with another medication, and to look for warning signs or symptoms warranting immediate attention, such as nausea, vomiting, diarrhea or abdominal pain.

The agency did not provide further details about the two deaths, which followed reports that four women in California had died of septic shock since 2003 after undergoing medical abortions, as the procedure for using RU-486 is called.

Planned Parenthood Federation of America reacted by saying it would immediately alter its procedures for administering the drug. The group had been recommending that women take the second drug vaginally, a widespread practice that is generally believed to be more effective but is not what the FDA recommends.

The four California women had also taken the drug vaginally.

In a statement, Planned Parenthood said one of the two recent deaths took place "weeks" after use of the pills and the second "several days" afterward. It emphasized that a tiny fraction of the 560,000 women who have taken the pills in the U.S. have died after their use.

According to the FDA, reports of fatal infections in women taking RU-486 are "very rare" - about one in every 100,000 cases. Studies show that the procedure is safer than giving birth.

After finding a link between use of the abortion pills and the four California deaths, the FDA issued a warning in July. In November, it updated its alert to say that all four women were infected with the same Clostridium sordellii bacteria.

In 2001, a Canadian woman died from the same type of infection after taking the drug during a clinical trial.

Controversial even before the FDA approved its sale six years ago, RU-486 has been - and remains - a flash point in the abortion wars. It ends a pregnancy, unlike the "morning-after" pill, which prevents one.

Government investigators have said that RU-486 poses a small risk to women and that the fatal infection that killed the four California women could occur in women giving birth as well. The infections are hard to detect because they do not produce fevers or other signs of infection.

Conservatives, concerned that hundreds of other deaths might have gone unreported, have called on the FDA to restrict sales. Liberal groups, countering that evidence shows the drug is safe, fear the agency will cave in to political pressure.

The FDA is meeting with the Centers for Disease Control and Prevention and the National Institutes of Health on May 11 to review the deaths associated with RU-486, sold as Mifeprex. Investigators are trying to determine whether use of the drug makes women vulnerable to infection.

Monty Patterson, who has been speaking out since his 18-year-old daughter, Holly, died in 2003 after taking the abortion pill, urged federal regulators to move more quickly.

"How many women have to die before this drug is removed from the market? It's time for the FDA to take action and be swift about this to save women," said Patterson, of Livermore, Calif.

Danco Laboratories, the New York manufacturer of RU-486, issued a statement saying it was "deeply saddened" by the deaths and was investigating.

RU-486 is supposed to be taken up to 49 days after conception and then followed a few days later by a companion drug, misoprostol. In Europe, most doctors and clinics have women take misoprostol orally. But in the United States, most insert it vaginally.

Dr. David Grimes, who directed abortion surveillance at the CDC during the 1980s, said vaginal administration is slightly more effective, but oral administration in Europe has not led to any deaths there.

For that reason, Grimes, who now works for a reproductive health group in Durham, N.C., called Family Health International, said Planned Parenthood took the right action in following the European model, which is what the FDA directions recommend.

jonathan.rockoff@baltsun.com

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