FDA advisory on mifepristone

The US Food and Drug Administration says it is investigating recently-reported serious adverse events associated with the morning-after, pregnancy-terminating agent mifepristone (trade name Mifeprex, also known as RU-486). As a result, the FDA has issued a public health advisory highlighting the risk of sepsis or blood infection when undergoing medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. There are now four cases of deaths from infection from September 2003 to June 2005 following medical abortion with these drugs, it stated.

"The FDA is committed to sharing emerging drug information with the public and 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, acting director of the agency's Center for Drug Evaluation and Research. Puts hold on Neose's NE-180 Ph I

The FDA has also placed on hold Neose Technologies' proposed Phase I clinical trial of NE-180, the firm's long-acting formulation of the protein erythropoietin, for the treatment of chemotherapy-induced anemia. This sent Neose' shares tumbling 20% to $3.35 on the day of the news breaking, July 20.