Initial FDA Data Reveals RU 486 Had Dangerous Complications
Source: Cybercast News Service; February 19, 2002

Washington, DC -- The dangeous abortion pill RU-486 can have serious side
effects and complications, but the federal government's requirements for
data collecting appear to do little to help advocates on either side of
the abortion issue make their case about the safety of the drug.

Food and Drug Administration data obtained by the Cybercast News Service
through the Freedom of Information Act (FOIA) regarding reports of adverse
side effects using RU-486 show only 33 individual reports entered into the
FDA database during a four year period between November 1997 and November
2001.

The data represent "side effects and complications arising from the use of
RU-486 during the time it has been available in the U.S. Market," wrote
Debra P. Taub, lead consumer safety officer for the Department of Health
and Human Services.

People taking one or both of the two-drug combination included men and
women, ranging from teenagers to people in their 70s.

The data do not specifically state the purpose for taking the drug; some
women appeared to be taking the drug to produce an abortion, based on the
dosages taken, while others used the drug to treat medical problems
unrelated to abortion.

Four men and 29 women were among those whose cases were referred to the
FDA, and the data show that five people for whom an adverse side effect
was reported died, with RU-486 or one of its components listed by doctors
as the primary suspected cause of death.

Among those reported deaths, three were men, representing 75 percent of
all the men included in the adverse side effect report.

Other adverse effects for which doctors listed RU-486 as the primary
suspect included nausea, dizziness, excessive bleeding, life-threatening
blood clots and infection, and respiratory distress.

Not counting the two women who died with RU-486 listed as the prime
suspect, responses to the various side effects among women included 22 who
required hospitalization or "intervention to prevent permanent
impairment," and five who experienced "life threatening" or "other"
medical outcomes.

Federal law requires all drug manufacturers to make such reports to the
Food and Drug Administration (FDA). It's a reporting system the FDA and
others say helps regulators keep an eye on a drug's side effects. However,
doctors are not required to report their findings to drug manufacturers, a
regulatory loophole that renders the data collecting spotty and far from
complete.

John Diggs, a pro-life Massachusetts doctor and advisor to the Family
Research Council, sees cause for alarm in the FDA data. "The number one
problem is that the drug is really bad," said Diggs.

"I am not surprised [at the adverse effects], because these are the
expected complications," he said. "The problem is the FDA chose to
overlook them."

Diggs and other pro-life advocates have been critical of the FDA for
giving RU-486 fast track approval in September 2000, using an expedited
process typically afforded drugs that have life-saving potential.

"Any drug like this that's causing those number of deaths under any other
circumstances would be withdrawn or at least studied," he said. "But this
one was pushed through under fast track, meaning that it bypassed all the
usual studies and the time and the peer review to make sure that a drug is
safe."

It's not known whether there's a direct link between the streamlined
approval process and the collection of 33 reports of adverse side effects
over a four-year period.

The drug's direct and indirect health complications were "completely
preventable and foreseeable, and many people commented on it before it was
approved," Diggs said.

At the very least, he said, the FDA should have required doctors to
perform an ultrasound before prescribing the drug for abortions, in case
the patient has an ectopic pregnancy, where the unborn child attaches to
the fallopian tube rather than the uterus. Ectopic pregnancies, Diggs
explained, cannot be treated without surgical abortion.

Abortion advocates, however, see something different in the government
data. Beverly Winikoff claims that RU-486 is relatively safe. She serves
as director of reproductive health for the Population Council, the
pro-abortion group that spearheaded the effort to gain FDA approval for
RU-486.

"I don't know who can vouch for the accuracy of all this," Winikoff said,
looking at the FDA data. "There can be errors in data entry," she
suggested, though "one has to assume that they're probably generally
accurate."

Winikoff, like Diggs, noted that abortion drug side effects are almost
certainly under-reported, since the FDA does not require doctors to do so.
But she said the reporting requirements during a drug's initial clinical
study are rigorous enough to identify most side effects and complications
before the drug is approved.

In addition, Winikoff claimed complications reported to the FDA were not
all caused by RU-486 itself. In one case, a 15-year-old girl was
hospitalized for pulmonary and leg blood clots after taking RU-486.

"She had an infection, it looks like," said Winikoff, reading the girl's
long list of medical complications. "That could have come from something
that was done to her in the hospital when the other stuff was being
treated.

Although Winikoff wouldn't necessarily consider some medical situations as
side effects of RU-486, she didn't completely discount the potential for a
link. "It's always a risk of any kind of abortion that someone can have an
infection. So, yes, this could be related to the abortion," she said.