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 Friday, 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, misoprostol -- and to look for warning signs warranting immediate attention.
The agency did not provide further details about the two deaths, which followed reports that four women in California had died from septic shock since 2003 after undergoing medical abortions, as the procedure for using RU-486 is called.
Planned Parenthood Federation of America said it would immediately alter its procedures for administering the drug. The group had been recommending that women take the misoprostol vaginally, a widespread practice that is generally believed to be more effective but is not what the FDA recommends. The four California women took 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 after. It emphasized that of 560,000 women who had taken the pills in the U.S., a tiny fraction -- seven -- had died afterward.
According to the FDA, reports of fatal infections in women taking RU-486 are “very rare” -- about 1 in every 100,000 cases.
After learning that the four California women who died had taken the abortion pills, the FDA issued a warning in July but said it did not know whether use of the abortion pills had caused the deaths. In November, it updated its alert to say that the women were infected with the same Clostridium sordellii bacterium.
Controversial even before the FDA approved its sale six years ago, RU-486 has been a flashpoint 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 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.
Some groups have called on the FDA to restrict sales, saying hundreds of deaths may not have been reported. Other groups say evidence shows that the drug is safe.
A May 11 workshop by the FDA, the Centers for Disease Control and the National Institute of Allergy and Infectious Diseases will review cases of clostridial infections, including the California deaths.
Investigators are trying to determine whether use of RU-486, sold as Mifeprex, makes women more susceptible to infection.