Information and Resources

FDA: 2 More Deaths With Abortion Drug

March 17, 2006 -- The FDA has received reports of two more deaths following medical abortion with the abortion drug RU-486 ( Mifeprex).

The FDA received verbal reports of the deaths from the drug's maker, Danco Laboratories. The causes of death aren't known yet, but the FDA is warning doctors to follow treatment guidelines and to watch for a severe infection.

"At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death," states an FDA news release.

"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," the FDA's news release continues.

"In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation," states the FDA.

Earlier Advisory

In July 2005, the FDA issued a public health advisory after learning of the deaths of four women in the U.S. who had had medical abortions using RU-486 and misoprostol.

The four women mentioned in the FDA's July 2005 advisory all died from sepsis, a severe infection of the bloodstream and vital organs, states the FDA. Those women also all tested positive for infection with the bacterium Clostridium sordellii. At the time, the FDA tested batches of the drugs and found no Clostridium sordellii contamination.

The FDA says it doesn't know yet if the two newly reported deaths were due to sepsis or if Clostridium sordellii infection was involved.

The FDA's latest advisory reviews RU-486's approved dosing regimen and reminds medical staff to check for infection and sepsis in patients who show signs of possible complications after medical abortion.