FDA Alerts on Mifeprex

Time is limited. Contact Our Lawyers.
Call us Toll Free at 1-866-242-0905 or
Click here to begin your FREE Case Review

FDA ALERT- [March 17, 2006] The FDA notified healthcare professionals of two additional deaths following medical abortion with mifepristone (Mifeprex). The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

FDA ALERT- [July 19, 2005] The FDA is aware of four women in the United States who died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with Mifeprex and misoprostol. Sepsis is a known risk related to any type of abortion. The symptoms in these cases were not the usual symptoms of sepsis. We do not know whether using Mifeprex or misoprostol caused these deaths. Patients should contact a healthcare professional right away if they have taken these medicines and develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking misoprostol. These symptoms, even without a fever, may indicate sepsis. Make sure your healthcare practitioner knows you are undergoing a medical abortion.

The law firm of Steigerwalt & Associates is here to help victims of Mifeprex RU-486 throughout the country.