Public health advisory issued for abortion pill

March 27, 2006

Following reports of two fatalities in women who took mifepristone (Mifeprex, Danco Laboratories) to terminate their pregnancies, the FDA has issued a public health advisory to providers and patients. The agency said they are investigating the cases, but at this time are not certain of the exact cause of death.

Public health advisory issued for abortion pill

Following reports of two fatalities in women who took mifepristone (Mifeprex, Danco Laboratories) to terminate their pregnancies, the FDA has issued a public health advisory to providers and patients. The agency said they are investigating the cases, but at this time are not certain of the exact cause of death. Mifepristone is approved for a medical abortion up to 49 days of pregnancy and should be used only according to the approved regimen. The FDA stressed that the tablets should not be inserted intravaginally as the safety and efficacy of this method have not been established. Healthcare providers should look for signs and symptoms that might suggest infection more than 24 hours after taking the drug and should consider obtaining a complete blood count in these patients. If physicians suspect an infection, treatment with antibiotics that cover anaerobic bacteria such as Clostridium sordellii should be started immediately. The FDA received four previous reports of confirmed deaths from sepsis between September 2003 and June 2005. All four cases tested positive for C. sordellii and involved an off-label dosing regimen.

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