Two die after taking RU-486
WASHINGTON – The Food and Drug Administration reported Friday that two more women have died after taking the RU-486 abortion pill, bringing to seven the number of fatalities associated with the drug since it was approved for use in 2000.
The agency said that it was investigating the new reports, provided by the manufacturer of the drug, but so far was not able to confirm any cause of death. In four earlier fatalities of California women who had undergone medical abortions, the victims died of a form of blood poisoning caused by Clostridium sordellii, a common but rarely fatal bacterium.
Opponents of abortion quickly described the FDA advisory as another reason to ban the abortion pill, sold as Mifeprex.
“RU-486 is a deadly drug that is killing pregnant women,” said Sen. Jim DeMint, R-S.C., who has cosponsored a bill to take the drug off the market pending a review. “This drug should never have been approved, and it must be suspended immediately.”
But supporters said that the pill, which has been used worldwide for years, remained safe.
“To put this in context … 560,000 medication abortions have occurred in North America and there have been seven reported deaths of women who had medication abortions,” said Vanessa Cullins, vice president for medical affairs of the Planned Parenthood Federation of America. “At this time, none of those deaths have been directly attributed” to the abortion pill.
According to the FDA, reports of fatal infections in women taking RU-486 are “very rare” – about 1 in every 100,000 cases. Studies show that the procedure is safer than giving birth.
Though commonly known as RU-486, this medical abortion actually entails taking two pills. The first, an antiprogestin, binds itself to wall of the uterus, triggering the shedding of the uterine wall and not allowing the embryo to become implanted. One or two days later, the woman takes another drug – misoprostol – which causes her cervix to soften and dilate so that the embryo can be expelled.
As a precaution, Cullins said that Planned Parenthood was changing its policy regarding how medical abortions should be administered. In the past, many women received misoprostol vaginally, although the FDA had never reviewed or approved that method. Vaginal use is considered to be more effective and has fewer side effects, but Cullins said that her organization would no longer recommend that method.
In its advisory, the FDA pointedly said that the safety and effectiveness of vaginal use of the second drug “has not been established.” It also said that providers of medical abortion and emergency room staffs should investigate the possibility of blood poisoning whenever women who have taken the drugs come in complaining of nausea, vomiting or weakness unassociated with fever or other signs of infection.
The FDA said Friday that it did not know whether the clostridium bacteria played any role in the most recent deaths, but the agency did establish that it was present in four earlier fatalities. One other death related to medical abortion was in a woman who had an ectopic pregnancy – a condition where RU-486 is not considered appropriate.
The issue of clostridium infection will be discussed at a May public workshop hosted by the FDA and the Centers for Disease Control and Prevention. The bacteria has been associated with a small number of deaths and more hospitalizations involving both medical abortions and skin grafts.
The agency’s handling of the seven deaths of women who had undergone medical abortion was criticized by opponents of the drug.
“The FDA has pulled other drugs that have caused fewer deaths and less severe complications than RU-486,” said Wendy Wright, president of Concerned Women for America. “Why the double-standard for an abortion drug that is now linked to the deaths of seven healthy women and over 800 other reported complications?”
Opponents of medical abortion filed a citizen’s petition with the FDA soon after the drug was approved for use, but the FDA has never acted on it.