16-November-2004 -- EWTNews Brief
WASHINGTON DC, USA, November 16 (CNA) - An
abortion pill that pro-life groups have raised the red flag about for years,
especially since the death of a teenager in 2003 who took the drug, received
additional warnings by the U.S. Food and Drug Administration yesterday.
Mifeprex, also known as RU-486 or the "abortion pill," can cause
serious bacterial infections and bleeding, said the FDA.
Some complications, which can be fatal, can occur without any obvious
symptoms, the FDA said in updating the drug's "black box" warning
label.
The FDA approved Mifeprex in 2000 for ending early pregnancies of 49 days or
less.
"FDA and (maker) Danco Laboratories have received reports of serious
bacterial infection, bleeding, ectopic pregnancies that have ruptured, and
death, including another death from sepsis (blood infection) that was recently
reported to FDA," the agency said in a statement. These reports have led to
the revision of the black box labeling.
The FDA said the risks are rare but important to note. The FDA said it will
continue to monitor the usage of Mifeprex and may take further action as needed.