Health
Abortion drug gets FDA warning
NEWS IN BRIEF — Posted Aug. 8, 2005
The Food and Drug Administration is warning physicians to be alert to the possibility that patients undergoing medical abortion using mifepristone may develop sepsis, particularly if the drug is not used in accordance with the labeling.
"We believe it is important to share with health care providers and patients the latest serious reports of infection associated with this drug that we have received," said Steven Galson, MD, MPH, acting director of the agency's Center for Drug Evaluation and Research.
From September 2003 until June 2005, the agency recorded four deaths due to sepsis following a medical abortion. The agency is particularly concerned because symptoms in these cases were unusual for sepsis and linked to a bacterium, Clostridium sordelli, that rarely causes illness.
Sepsis is a known risk of any type of abortion. The agency has not conclusively linked these cases to the use of the drug.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/08/08/hlbf0808.htm.
