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BY OUR PHARMA CORRESPONDENT
July 23, 2005: Mifepristone, a medical abortion drug is facing problems. The United States FDA (US FDA) has issued a public health advisory on Mifepristone (also known as Mifeprex and RU-486). FDA is also investogating serous negative events associated with the use ofthe drug. Risk of sepsis or blood infection are warned to be associated with the drug. FDA believes that these adverse effects are not consistent with the labelling on the drug. Following medical abortion with abortion drug Mifepristone, there are now four cases of deaths reported from September 2003 and June 2005.
According to Dr Steven Galson, Acting Director of FDA's Center for Drug Evaluation and Research, "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."
In two of the reported deaths after use of abortion drug Mifepristone, the bacteria which is belived to have caused the fatal infection have been identified. The other two cases are being investigated by the FDA, along with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of Mifeprex. FDA has advised doctors to maintain a higher level of suspicion for sepsis in patients taking Mifeprex (Mifepristone drug).
Earlier, the FDA has received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death. Those reports led to the revision of the black box labeling. Mifeprex was approved by the FDA in 2000.
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