rom: The Pro-Life Infonet <infonet@prolifeinfo.org>

Reply-To: Steven Ertelt <infonet@prolifeinfo.org>

Subject: FDA Defends RU 486 Abortion Drug Despite Latest Report

Source: Cybercast News Service; April 18, 2002

FDA Defends RU 486 Abortion Drug Despite Latest Report

Washington, DC - An official from the Food and Drug Administration Thursday defended the dangerous abortion-inducing drug combination RU-486

-- despite acknowledgement from the maker of the drug that two women who were on RU-486 died and four others became very sick.

According to a report in Thursday's Washington Post, Danco Laboratories, the maker of the drug marketed as Mifeprex, has sent a letter to doctors,

telling them about the six women.

The letter, however, also says it's not known if RU-486 actually caused the deaths and illnesses. According to the newspaper report, three women

suffered bleeding caused by the rupture of ectopic (fallopian tube) pregnancies; one died. Two other women had serious bacterial infections;

one of them died. The sixth patient had a heart attack three days after taking RU-486, but she recovered.

The letter Danco sent to doctors reminded them to report any serious problems in women who take the abortion drug combination.

The Food and Drug Administration (FDA) official, who agreed to speak only on background, said the RU-486 regimen was not responsible for the two

deaths or for most of the other complications.

In the case of the ectopic pregnancies, the women took RU-486 unaware of the ectopic condition, the official explained. Only later did they

discover that RU-486 had not caused an abortion. "A while later she starts having abdominal pain and bleeding [and] she thinks it's because she had

an abortion," the official explained.

The Danco letter is meant to "remind clinicians that just because someone has had [an] abortion [regimen], there is still that possibility of

ectopic pregnancy," said the official.

The woman who died after complications from the ectopic pregnancy was an unusual case, according to the official.

"There's reason to believe that she simply didn't believe this is what was happening to her," said the official, because the "MedWatch" report showed

the woman had contact with a doctor and was urged to seek medical care.

In the cases of bacterial infections that followed the use of RU-486 could not be attributed to the use of the drug, because even if the women had

not taken the drug, they could have gotten the infections, anyway, from a miscarriage or from normal childbirth.

"This kind of thing is rare, but it does happen in rare cases" with normal childbirth or miscarriage, the official explained. "It can't be attributed

to the drug" because there is no evidence that points in that direction.

The 21-year-old woman who suffered a heart attack, said the official, is again a different matter.

"There are all kinds of reasons for heart attacks," said the official. "Without further background info to know what happened, one certainly

could not attribute" the heart attack to RU-486.

The FDA official defended the lag time of several months between the reported incidents and the FDA-approved Danco letter.

"It always takes some time to sort through these things, determine what significance there may be and decide what is important to tell the public

and decide what sort of action should be taken.

Telling citizens about the potential for a misdiagnosis of ectopic pregnancies, the official warned, could "cause people to have undue fear

of a drug that's not warranted."

However, a Danco spokesperson said the company has always divulged the relevant information about ectopic pregnancies in a patient information

kit that accompanies shipments of RU-486. Also included is an informed consent form for doctors to get patients to sign.

"The ectopic pregnancy [information is in] the current product labeling and patient information that walks patients through what to expect," said

Danco spokesperson Heather O'Neill.

The Danco letter, added O'Neill, is a reminder for doctors to have a plan for management of diagnosis and treatment in the event of an ectopic

pregnancy.

"The key point here is that the regimen is safe and effective," she concluded.

The FDA approved RU-486 as an abortion-inducer in September 2000, and at the time, pro-life groups warned of its dangers. News reports about the

deaths and complications prompted criticism from pro-life organizations.

"The FDA approved RU-486 under intense political pressure, and now women are suffering the consequences," said Wendy Wright, senior policy director

for Concerned Women for America.

"Abortion lobbyists should stop putting their political agenda above women's health and end their advocacy and distribution of RU-486," said

Wright.