May 11, 2006

Health experts say cause for concern over “abortion pill”

By Susan Heavey

ATLANTA (Reuters) - Reports of rare bacterial infections,
including a handful of cases in women who have taken the
controversial RU-486 abortion pill, are cause for concern and
warrant further study, U.S. health experts said on Thursday.

Two sometimes fatal bugs -- Clostridium sordellii and
Clostridium difficile -- are a particular worry as antibiotic
resistance grows and infections occur in people without typical
risk factors, doctors and researchers said.

While the infections also have been reported in drug users,
surgical patients and accident victims, including men, those
found in women taking the pill drew the most scrutiny at a
public meeting at the Centers for Disease Control and
Prevention's Atlanta headquarters.

Officials from the CDC, the Food and Drug Administration
and the National Institutes of Health are seeking advice from
outside experts to decide what research is needed to understand
and track the infections.

Paul Seligman, associate director for safety policy at the
FDA, said it was unclear what was triggering the new clusters
of cases.

"What we do know is that in this country we are seeing the
simultaneous emergence of two virulent, often fatal illnesses
affecting otherwise healthy people," he said at the meeting.

Drawing the most scrutiny are at least 15 cases in pregnant
women, including 10 fatal infections reported recently in women
who had given birth or who had miscarriages.

Another six women who took RU-486, also known as Mifeprex
or mifepristone, have died since 2000. Officials linked four of
the cases to infection but could not tie them to the drug.
Another case is under investigation and another was ruled

Representatives of several women's groups and others who
support RU-486 have said the infections were important to
investigate, while anti-abortion groups saw the meeting as a
first step to ban the pill.

Dozens of U.S. lawmakers, mostly Republican, back
legislation calling for the drug's withdrawal, and
anti-abortion groups also have petitioned the FDA.

The drug, made by Danco Laboratories LLC, is taken with
another drug called misoprostol early in pregnancy to trigger
an abortion. It is unrelated to emergency contraception sold by
Barr Pharmaceuticals Inc. under the name Plan B.

While abortion supporters and opponents attended the
largely academic meeting, it was free of fervent protest often
found at events that touch on abortion issues.

Instead, agency officials focused on scientific evidence.

FDA's Seligman said thousands of Clostridium difficile
cases occur each year in the United States. The
diarrhea-causing disease is usually treatable but has recently
become more difficult to treat.

Clostridium sordellii is far more rare and previously was
not known to be toxic. "Over the past few years the picture has
changed," Seligman told the panelists.

Two experts singled out the abortion pill as a problem.
University of Colorado Health Sciences Center gynecologist
James McGregor urged officials to "reduce or eliminate" use of

Overall, most experts from state public health offices,
hospitals and universities encouraged further study.

"We clearly need controlled trials," said Dale Gerding, an
associate chief of staff at Hines Veterans Affairs Hospital in

It was not immediately clear what future action the FDA
might take regarding RU-486 or antibiotic use.

All three agencies will carefully weigh the information
presented, Seligman said, adding that "developing a realistic
set of expectations" about how long it will take to understand
the infections would play a part in deciding what, if any,
action the FDA might take."