Foes of abortion pill want drug off market
WASHINGTON – Opponents of the abortion pill RU-486 are mounting a renewed campaign to force the Food and Drug Administration to pull the drug from the market, arguing that it has proven unexpectedly dangerous to women.
The effort focuses on the deaths in recent years of four to eight young women who had taken the medication, and especially the four deaths that involved a common but rarely fatal bacterium, Clostridium sordelli. A congressional committee plans a hearing today on what it called “the unsafe characteristics of RU-486.”
But research into those lethal infections has unearthed new information that makes it less clear that complications from the abortion pill, sold as Mifeprex, actually caused the deaths.
The FDA and Centers for Disease Control and Prevention have implicated the Clostridium bacterium in the deaths of more than a dozen other women after childbirth or miscarriage – making it unclear whether there is any cause-and-effect relationship between the abortion pill and the infections.
“We think it’s premature to say there is any direct relationship between (RU-486) and these Clostridium deaths,” said Sandra Kweder, deputy director of the agency’s Office of New Drugs. “The situation is far more complicated than we originally imagined, and far more broad than anything limited to this drug.”
Nonetheless, opponents of abortion and the abortion pill say the risk of Clostridium infection after medical abortions is great enough to warrant immediate withdrawal of the drug. Today’s hearing before the House Subcommittee on Criminal Justice, Drug Policy and Human Resources, chaired by Rep. Mark Souder, R-Ind., is intended to highlight the drugs’ alleged dangers.
“Considering the evidence we have of deaths and serious side effects, the maker of this drug should have taken it off the market long ago,” said Michelle Gress, counsel to the committee and spokeswoman for Souder.
Souder is one of 83 co-sponsors of a bill that would force the drug off the market. Called Holly’s Law – after Holly Patterson, an 18-year-old California woman who died of a virulent infection after using Mifeprex – the legislation has a companion bill in the Senate.
RU-486 was approved by the FDA in 2000 for medical abortions for women up to 49 days pregnant. The drug blocks production of the hormone progesterone, which is needed to nourish the fetus, and, when taken in conjunction with a second medication that induces contractions, results in an abortion.
Abortion rights advocates welcomed the long-awaited approval of the drug – in the last days of the Clinton administration – as a way to make abortion services more broadly available, especially to women in areas where there are few if any abortion providers. The maker of Mifeprex, Danco Laboratories, says that about 575,000 American women have used the drug since its approval, and millions more worldwide.