U.S. lawmakers renew call for abortion pill ban
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Several conservative lawmakers on Wednesday urged Congress to order a halt to sales of the abortion pill RU-486 and require further safety review after the drug’s maker announced that five women taking it had died from bacterial infections.
The Food and Drug Administration on Tuesday alerted the public to the deaths and new warning information on the drug’s label. But the lawmakers said that is inadequate.
“Congress needs to act to take this deadly drug off the market and force a serious review of its safety,” said South Carolina Republican Sen.
Jim DeMint, who joined with Republicans Sam Brownback of Kansas and David Vitter of Louisiana to back new legislation. The three lawmakers oppose abortion.
Pennsylvania Republican Rep. Melissa Hart, who joined them at a news conference, is sponsoring companion legislation in the House.
RU-486, also known as Mifeprex or mifepristone, is approved for terminating a pregnancy of 49 days or less.
Abortion opponents fought vigorously to keep it off the U.S. market and have asked the FDA to revoke the approval.
More than 460,000 U.S. women have taken Mifeprex since it was approved in September 2000, according to the drug’s maker, Danco Laboratories LLC.
The privately held firm announced the deaths on Monday. Three cases involved a rare bacterium known as Clostridium sordellii.
One death occurred during a clinical trial in Canada in 2001, Danco said. The other four were reported in California—two in late 2003, one in early 2004 and one in mid-2005.
FDA officials issued their own warning on Tuesday but said the number of deaths was not alarming, equaling about 1 in 100,000.
“There are no alarm bells going off because of this rate, but we are watching it very closely,” Dr. Steven Galson, acting director of the FDA’s drug center, told reporters Tuesday.
The lawmakers at the news conference suggested the death rate may be higher and that doctors and coroners may not have been aware of a potential link between a woman’s death and the drug.
New York-based Danco said it would send a letter alerting physicians to the deaths and update warning information on the drug’s label.
The new label is designed to encourage doctors to look for signs of unusual infections, such as cases without fever, Galson said.
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