The FDA has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex) and is investigating the circumstances associated with the cases. The agency is making all providers of medical abortions aware of the specific circumstances and directions for use of this drug and all risks, including sepsis, when considering treatment.
In particular, providers and patients should fully discuss early signs and symptoms that may warrant immediate medical evaluation.
The approved regimen for mifepristone for a medical abortion through 49 days pregnancy is specified in the advisory along with information about sepsis and its symptoms.