LOS ANGELES (AP) — Federal health investigators have ordered a reworking of the warning label on the abortion pill commonly known as RU-486 after the baffling deaths of four California users from bloodstream infections.
“On the surface, this appears unusual,” said Dr. Marc Fischer, a medical epidemiologist at the federal Centers for Disease Control and Prevention in Atlanta. “That’s why we’re investigating.”
Two of the deaths, one this year and one last year, were reported last week by the Food and Drug Administration. The other two deaths occurred in 2003. All were caused by sepsis, a bloodstream infection, although the women didn’t have all the usual symptoms for sepsis, such as fever, health officials say.
The new warning label on Mifeprex, also known as RU-486 or mifepristone, will be updated to alert women and doctors in more detail to unusual, dangerous infections that are not always accompanied by fever. The FDA has not officially blamed Mifeprex for the deaths and says the drug is safe enough to stay on the market.
The drug’s maker, New York-based Danco Laboratories LLC, agreed to change the warning label, but has defended the pill’s record, saying there is no evidence Mifeprex caused the bacterial infection and sepsis.
Mifeprex is taken as two pills at different times. None of the women who died had followed FDA-approved instructions for taking the drug, and authorities are looking into whether that may have played a role in their deaths.
More than 460,000 women in the United States have used Mifeprex since it was invented in France in the 1980s. The pill contains a “black-box” warning highlighting the risk of bacterial infection, sepsis and death. Reports of fatal sepsis among the pill’s users are rare, occurring in one in 100,000 cases.
The FDA calls for both pills to be swallowed, but the agency says it is aware that many abortion clinics and doctors recommend that the second pill be inserted vaginally based on studies that have shown its effectiveness in ending a pregnancy.
Dr. Vanessa Cullins, vice president of medical affairs at Planned Parenthood Federation of America Inc., said she thinks vaginal insertion is safe. Abortion clinics counsel women on making sure their hands are clean before they insert the pill to avoid infection, Dr. Cullins said.
Federal drug regulators are not sure whether this so-called “off-label use” might have contributed to the deaths, but it is one of the areas being investigated.