Mifeprex already carries a warning about the possibility that women who take the drug could experience serious and sometimes fatal infections. The company is updating the label to give physicians more information to help them spot the problem, Danco spokeswoman Cynthia Summers said.
"Childbirth, menstruation and abortion, whether spontaneous, surgical or medical, all create conditions that can result in serious and sometimes fatal infection, and there is no evidence that Mifeprex and misoprostol present a special risk of infection," the company says in a statement.
RU-486 is approved for terminating a pregnancy of 49 days or less. Abortion opponents fought vigorously to keep it off the U.S. market and have asked the FDA to revoke the approval, according to a Reuters medical report.
More than 460,000 U.S. women have taken Mifeprex since September 2000, Danco said.
