U.S. Food and Drug Administration announced today important safety changes to the labeling of the abortion pill Mifeprex, also known as RU-486, after receiving reports linking the drug to serious bacterial infection.

Mifeprex, made by Danco Laboratories, was approved in 2000 for the termination of early pregnancy, defined as 49 days or less.

Both the F.D.A. and Danco have received reports linking Mifeprex to serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, the agency said in a press release. These reports led to the safety changes announced today.

The abortion drug already carries a “black box” warning label, which is FDA’s strongest alert. But the revised label will include new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all, the agency said.

(via U.S. Food and Drug Administration)