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Two more deaths may be connected to mifepristone use.

Two additional deaths following medical abortion with mifepristone (Mifeprex) have prompted the Food and Drug Administration to issue a public health advisory alerting health care providers and advising review of the prescribing information.

The drug's manufacturer, Danco Laboratories, notified the agency of the deaths, which took place in the United States. The FDA is investigating the cases but cannot yet confirm the causes of death.

The agency advises physicians to discuss with their patients the risk of sepsis as well as early signs and symptoms that may warrant immediate medical evaluation. In addition, the FDA advises physicians and emergency department personnel to investigate the possibility of sepsis in patients who are undergoing medical abortion and present with nausea, vomiting, or diarrhea; weakness with or without abdominal pain; and without fever or other signs of infection more than 24 hours after taking misoprostol. In particular, strong consideration should be given to obtaining a complete blood count to identify those patients with hidden infection.

The FDA recommends that if physicians suspect infection in patients with this presentation, they should consider immediately initiating treatment with antibiotics that include coverage of anaerobic bacteria, such as Clostridium sordellii. However, the agency does not recommend the use of prophylactic antibiotics at this time.

Four previous deaths from sepsis have been confirmed in the United States in women following medical abortion with mifepristone and misoprostol from September 2003 to June 2005. All four cases tested positive for C. sordellii. For more information, visit www.fda.gov/cder/drug/infopage/mifepristone/default.htm.
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Author:Wachter, Kerri
Publication:OB GYN News
Date:Apr 15, 2006
Words:255
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