# **[FACT: RU-486 kills]{.underline}**

But don't take my word for it,

read the *Washington Post*

Dear Colleague:

I commend your attention to a recent article from the *Washington Post*
(link and article copied below) regarding RU-486. Since its approval in
September of 2000, there have been numerous stories about the severe
health side effects - and even fatalities - caused by this
abortifacient.

Sadly, there have been two deaths recently, and others reported in the
past. Serious problems clearly occur when RU-486 is given to women with
ectopic (tubal) pregnancies, but numerous other cases of severe health
side effects have also been reported. Hemorrhaging, uterine rupture and
heavy bleeding are all potential side effects. RU-486 has the real
potential to cause major health care trauma for women nationwide.

HR 482, the Women's Health and Safety Protection Act, would help address
this situation by instituting real and reasonable patient protections
for women, bringing them to the level of those originally proposed
during the approval of RU-486. Those commonsense protections include:

-   Provisions for ultrasound testing, so that tubal pregnancies can be
    taken into account.

-   Provisions to ensure doctors who prescribe RU-486 can appropriately
    handle any complications.

-   Provisions that ensure women have the timely access they need to
    hospitals in case some of the reported severe health side effects
    occur.

Yes, RU-486 causes an abortion, but Congress can act to help make sure
it doesn't take the life of the mother as well. For more information,
please contact Greg Facchiano at 5-3015.

Sincerely,

David Vitter

Member of Congress

<http://www.washingtonpost.com/wp-dyn/articles/A5102-2002Apr17.html>

## Physicians Sent Abortion Pill Alert 

Six Women Using RU-486 Taken Ill, and Two Died, Letter Says

By Susan Okie

Washington Post Staff Writer

Thursday, April 18, 2002; Page A02

The company that makes the abortion pill RU-486 has sent a letter
informing doctors that six women have developed serious illnesses and
two have died after taking the drug to induce abortions. No causal
relationship has been established between the drug and the illnesses in
any of the cases, the letter said.

Three women who took the drug, also known as mifepristone or Mifeprex,
in combination with another drug called misoprostol to induce abortion
later suffered bleeding caused by rupture of ectopic pregnancies, an
abnormally located type of pregnancy that is not terminated by the drug
treatment. One woman died.

Two other women developed serious bacterial infections after receiving
the two-drug combination for medical abortions, and one of them died.

The sixth patient, a woman, 21, had a heart attack three days after
taking RU-486 and misoprostol. She recovered, said Heather O\'Neill,
director of public affairs for Danco Laboratories, the maker of
Mifeprex. The woman\'s mother had heart disease at \"a young age\" but
she had no other known risk factors, O\'Neill added.

A Food and Drug Administration official said the agency worked with
Danco on the letter, which was sent to inform all doctors who have
ordered Mifeprex from the company about the cases and to remind them to
report any serious adverse events in women receiving the drug.

\"These are, in fact, a very small number of events. Some of them were
clearly not caused by the drug regimen,\" the official said.

Opponents of the abortion regimen have long argued that the drug
combination is dangerous. Some predicted that if RU-486 were approved
and widely used, the incidence of heavy bleeding and other serious side
effects would be higher than that seen in studies.

Ectopic pregnancies occur in 2 percent of all pregnancies and are
usually located in the fallopian tube. They are not aborted by the
two-drug regimen, and continue to develop until they cause symptoms or
rupture and bleed. Mifeprex is approved for abortion during the first
seven weeks of pregnancy. At that early stage it is not always possible
to diagnose an ectopic pregnancy by the routine pelvic examination that
most women receive before an abortion.

In the letter sent to doctors Tuesday, Danco warned physicians to \"be
mindful of the possibility of an ectopic pregnancy\" in women given the
two-drug abortion regimen and to \"have a plan for its management.\"

Serious bacterial infections occur in an estimated 3.5 out of 1,000
pregnancies. Such infections also can sometimes occur during
menstruation and after childbirth and abortion.

\"We do not believe that Mifeprex and misoprostol present a special risk
of infection,\" the letter said. The fatal case of infection, caused by
the rare bacterium Clostridium sordellii, was first reported last year.
O\'Neill said the type of bacteria responsible for the second case was
not identified.

The heart attack case is the first that has been reported in a woman who
received Mifeprex and misoprostol, the FDA official said. Some heart
attacks occurred in women who received RU-486 in combination with a
different drug during studies done several years ago, she added. That
regimen is no longer used. Heart attacks are extremely rare in women in
their twenties, occurring in fewer than 1 out of 100,000 women aged 20
to 24.

\"This is a rare case, and it\'s a single event. We don\'t have any
information to establish any cause-and-effect relationship between the
drug regimen\" and the heart attack, the official said.

Mifeprex was approved by the FDA for abortion in September 2000 and
reached clinics and doctors\' offices two months later. Danco has
declined to release figures on how many women in the United States have
had abortions with the drug.

\"The events that are described in the letter represent an extremely
small incidence relative to overall usage of Mifeprex in the United
States,\" O\'Neill said.

The FDA official said that even though the number of cases is small, the
agency wanted to inform doctors \"that if symptoms of such events were
to occur, that physicians should be alert to them.\"

An ultrasound test can diagnose an ectopic pregnancy, and some abortion
providers perform such tests before giving women the two-drug regimen,
the official said.

A woman who does not experience the amount of vaginal bleeding that
usually occurs after taking the drugs may have an ectopic pregnancy and
should undergo further tests, O\'Neill said.

The FDA-approved regimen for Mifeprex and misoprostol specifies that
both drugs should be taken orally, but some doctors who use the drugs
instruct women to insert misoprostol in the vagina. The agency has no
information linking vaginal use with any of the adverse effects reported
in the letter, the FDA official said.

The agency also released changes in the labeling of misoprostol (or
Cytotec, manufactured by Pharmacia) which specify that the drug may be
used late in pregnancy to induce labor and delivery. The new labeling
warns that during late pregnancy, rupture of the uterus can occur in
women who receive high doses or in those who have had prior uterine
surgery or five or more previous pregnancies.

© 2002 The Washington Post Company