July 18, 2005
Abortion pill maker alerts doctors to five deaths
WASHINGTON (Reuters) - Five women who took the abortion
pill RU-486 have died from bacterial infections since its U.S.
introduction nearly five years ago, the manufacturer reported
"No causal relationship between these events" has been
established with the drug, also known as Mifeprex or
mifepristone, maker Danco Laboratories LLC said.
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 said in a statement.
Misoprostol is a drug that women must take two days after
Mifeprex to complete the abortion.
Danco said it was sending a letter to alert physicians
about the cases and updating warning information on the drug's
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.
"With these very rare infections, we want people to be able
to recognize them early," she said.
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.
More than 460,000 U.S. women have taken Mifeprex since
September 2000, Danco said.
One of the deaths occurred during a clinical trial in
Canada in 2001, the company said. The other four were reported
in California. Two of the California deaths were reported in
late 2003, one in early 2004 and one in mid-2005.
Three of the cases involved a rare bacterium known as
Clostridium sordellii, Danco's statement said.
Women who take Mifeprex and misoprostol should contact a
doctor or visit an emergency room immediately if they
experience abdominal pain or discomfort or general malaise more
than 24 hours after taking misoprostol, Danco said.