Two more women have died after using the abortion pill RU-486, regulators said Friday in a warning that brought renewed demands to pull the controversial drug from the market.
The organization that provided the pill to the two women said it would stop immediately disregarding the approved instructions for the pill’s use.
The Food and Drug Administration warned doctors to watch for a rare but deadly infection previously implicated in four deaths of women who had taken the drug. The drug, also called Mifeprex or mifepristone, has not been proved to have caused any of those deaths.
Nor has the FDA confirmed the cause of the latest two deaths. However, in one of them, the woman’s symptoms appeared to resemble those in the cluster of four cases in California where the women died from sepsis, an infection of the bloodstream. Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later.
Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, an “off-label” use that studies have shown effective and that has been recommended by most of the nation’s abortion clinics. That use does not have federal approval, although studies have indicated it produces fewer side effects.
It was not immediately known whether the second course of pills had been inserted vaginally in the two latest women to die, an FDA spokeswoman said. She declined to be identified, saying she was not authorized to speak publicly about the issue.
Two Senate abortion foes, Republicans Jim DeMint of South Carolina and Tom Coburn of Oklahoma, urged passage of legislation that would suspend sales of RU-486 until the Government Accountability Office reviews how the FDA approved the pill.
“RU-486 is a deadly drug that is killing pregnant women,” DeMint said. “This drug should never have been approved, and it must be suspended immediately.”
Monty Patterson, a California man whose 18-year-old daughter, Holly, died in 2003 after taking the abortion pill, also said the drug should be pulled. The Senate bill is informally called “Holly’s Law.”
“The bottom line is that this is not about the abortion debate. This is about the safety, health and welfare of women,” Patterson said.
Meanwhile, Planned Parenthood Federation of America Inc. said it would immediately stop recommending vaginal insertion of the final course of pills. Four of the women who died, including the latest two, received the pills at Planned Parenthood-affiliated clinics, said Dr. Vanessa Cullins, the organization’s vice president for medical affairs. Planned Parenthood estimates RU-486 has been used 560,000 times in the U.S. since it was approved.
RU-486 is sold by Danco Laboratories and is approved to terminate pregnancy up to 49 days after the beginning of the latest menstrual cycle. It blocks a hormone required to sustain a pregnancy. When followed two days later by another medicine, misoprostol, to induce contractions, the pregnancy is terminated.
The FDA previously has said the abortion pill remains safe enough to stay on the market. The rate of sepsis is about one in 100,000 uses, comparable to infection risks with surgical abortions and childbirth.
At least seven U.S. women have died after taking the pill, sold since 2000. The other U.S. death associated with Mifeprex was the 2001 case of a ruptured ectopic, or tubal, pregnancy. The drug is not to be used in those cases, in which the fertilized egg implants outside the uterus.
In the California cases, all four women tested positive for Clostridium sordellii, a common but rarely fatal bacterium.