In The Faith - A Chronicle of the Christian Faith

LOS ANGELES - Federal health investigators are baffled: Why have four California women died from a bloodstream infection after using a controversial abortion pill?

Two of the deaths — one this year and one last year — were reported last week by the
Food and Drug Administration. The other two deaths occurred in 2003. All were caused by sepsis, a bloodstream infection, although the women didn’t have all the usual symptoms for sepsis, such as fever, health officials say. Only one other U.S. death linked to the drug has been reported since it went on the market in 2000, and the cause of death in that case was different.

“On the surface, this appears unusual,” said Dr. Marc Fischer, a medical epidemiologist at the federal Centers for Disease Control and Prevention in Atlanta. “That’s why we’re investigating.”

Sold as Mifeprex, and also known as
RU-486 or mifepristone, the drug is taken as two pills at different times. None of the women who died followed FDA-approved instructions for taking the drug, and authorities are looking into whether that may have played a role in their deaths.

The FDA said it believes Mifeprex is safe enough to stay on the market and that there is no proof it caused the deaths. However, the label will be updated to alert women and doctors in more detail to unusual, dangerous infections that are not always accompanied by fever.

More than 460,000 women in the United States have used Mifeprex since it was invented in France in the 1980s. The pill already contains a “black-box” warning highlighting the risk of bacterial infection, sepsis and death. Reports of fatal sepsis among the pill’s users are rare, occurring one in 100,000 cases.

The drug’s maker, New York-based Danco Laboratories, has defended the pill’s record, saying there is no evidence Mifeprex caused bacterial infection and sepsis. However, the company agreed to change the warning label so patients and doctors know about the risk of rare infections.

p. [ Full Story @ Yahoo.com ]

p(small). Source: Yahoo.com © 2005 Associated Press

p(small). Related websites (not necessarily endorsed by In The Faith):
Food and Drug Administration
Danco Laboratories

p(small). Technorati:
Abortion Abortion pill RU-486 Mifeprex mifepristone FDA Food and Drug Administration Disease Control and Prevention Danco Laboratories Associated Press Yahoo.com Listen to this podcast

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