Drug & Device News

The Food and Drug Administration (FDA), which is investigating recently reported serious adverse events associated with mifepristone (trade name Mifeprex', also known as RU-486, or the “Morning After” pill), issued a public health advisory July 19 highlighting the risk of sepsis when undergoing medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. Between Septem-ber 2003 to June 2005, four deaths were blamed on these drugs. The bacteria thought to have caused the fatal infection has been identified in two of the cases. The other two cases are under investigation by the FDA in cooperation with the Centers for Disease Control and Prevention, state and local health departments and the manufacturer of Mifeprex. Doctors are urged to have a higher level of suspicion for sepsis in their patients taking Mifeprex. The FDA, which has of late been accused of “sitting on” information about possible drug dangers, seems to be taking a more open attitude about informing the public and health care community when drug problems occur. Dr. Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research, said in a statement released along with the warning about Mifeprex, “The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with healthcare providers and patients the latest serious reports of infection associated with this drug that we have received.”