US to weigh infections in "abortion pill"
By: Administrative Account | Source: Reuters
May 11, 2006 6:39AM EST
By Susan Heavey
ATLANTA (Reuters) - U.S. health officials, under pressure from conservatives to pull the abortion pill Mifeprex off the market, will hold an open meeting on Thursday to discuss rare bacterial infections in women who took the drug.
Six women who took the pill have died since the controversial drug was approved five years ago, although the Food and Drug Administration has not attributed their deaths to the drug.
Officials hope to keep the meeting, at the CDC's Atlanta headquarters, focused on science despite the continuing political battle over abortion. Supporters and opponents plan to attend the discussion, which is open to the public.
Dozens of U.S. lawmakers, mostly Republican, back legislation calling for the withdrawal of the drug, also known as mifepristone or RU-486. Three anti-abortion groups also filed a petition with the FDA in 2002 seeking a ban.
Of the six fatalities, three involved the rare bacterium Clostridium sordellii. In four cases, women were given part of the drug regimen vaginally, an unapproved method. Another death was not related, the FDA concluded, and the remaining case is under review.
The drug, made by Danco Laboratories LLC, is taken with another drug called misoprostol early in pregnancy to trigger an abortion. It is unrelated to emergency contraception sold by Barr Pharmaceuticals Inc. under the name Plan B.
The meeting, convened by the FDA along with the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases, will discuss the infections and decide what, if any, research is needed.
U.S. health officials will also ask a panel of mostly outside experts to review related infections in tissue graft patients and outbreaks of Clostridium difficile bacteria infections in several states. The meeting's goal "is to bring together scientific and public health experts to develop a draft research agenda" that can lead to a better understanding of the infections, according to the FDA, which said it was not planning any regulatory decisions following the discussion.
New York-based Danco has said about 575,000 women have taken Mifeprex since its approval and there is no evidence linking it to the deaths.
Eight fatal cases of Clostridium sordellii infection in women who had just given birth have also been reported in medical literature. The CDC also said last month it had discovered reports of two fatal cases of the same infection in women who had miscarriages in their second trimester.
Amy Allina, policy director for the National Women's Health Network, said it is important to investigate the pill-related cases, but that increasing bacterial infections of all kinds are a growing public health concern.
"From a drug safety perspective ... (the mifepristone cases are) a pretty low rate of problems compared to many drugs on the market," she said.
The National Right to Life Committee said there is enough research to show Mifeprex is too risky. "The most responsible thing to do would be to pull this drug off the market," said Randall O'Bannon, education director of the group.
(Additional reporting by Lisa Richwine)
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