Two additional deaths after 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 prescribing information.
The drug's manufacturer, Danco Laboratories, notified the agency of the deaths, which took place in the United States.
One of the deaths has since been determined to not be related to either an abortion or to the use of mifepristone and misoprostol. The FDA is investigating the other death, which involved symptoms of infection.
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 all of the following:
▸ Nausea, vomiting, or diarrhea.
▸ Weakness with or without abdominal pain.
▸ No fever or other signs of infection more than 24 hours after taking misoprostol.
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 U.S. women following medical abortion with mifepristone and misoprostol from September 2003 to June 2005. All four cases of fatal infection tested positive for C. sordellii.
For more information, go to: www.fda.gov/cder/drug/infopage/mifepristone