FDA Issues New Warnings About Abortion Drug

By Susan Jones | July 7, 2008 | 8:05 PM EDT

(CNSNews.com) - The Food and Drug Administration is attaching new health warnings to the abortion-inducing drug RU-486, also known as mifepristone or by its trade name Mifeprex.

One pro-abortion group said it supports the new warning label; but a pro-life group said label changes aren't enough - the drug should be pulled off the market entirely.

The FDA approved Mifeprex in 2000 for the termination of early pregnancy, which was defined as 49 days or less.

Since then, the FDA and the drug's maker, Danco Laboratories, have received reports of serious bacterial infection, bleeding, ectopic pregnancies, and even death in several cases - and the new warning label will mention those complications.

The label also will inform health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness. The FDA also said health care providers should be aware that prolonged, heavy bleeding may warrant surgery.

The label also warns health care providers to watch for patients with undiagnosed ectopic pregnancies (tubal pregancies), a condition that may be overlooked by physical examination and ultrasound.

Women taking the drug should immediately report fever, abdominal pain, and heavy bleeding, the new label will say.

The FDA said the revised labeling "will provide physicians and patients with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion."

The FDA said it will continue to monitor the usage of Mifeprex-"and may take further action."

'Warnings not enough'

Concerned Women for America, a conservative public policy group, notes that several women have died after taking RU-486, and the FDA's response is simply to change the drug's label.

"This is a dangerous drug that deserves to be pulled off the market immediately," said Wendy Wright, CWA's senior policy director. "Not only is the drug unsafe, but abortionists refuse to follow the FDA's current guidelines -- even after Holly Patterson's tragic death." Wright added.

Patterson, 18, died in September 2003 after taking RU-486 at home.

"Why would anyone think that by the FDA changing words on a label, abortionists will suddenly put women's health and lives above their own convenience and profits? How many more women must die before the FDA acknowledges the perilous realities of this drug and removes it from the market?" asked Wright.

After Patterson's death, Concerned Women for America said it filed extensive evidence with the FDA showing that the drug was not adequately tested; that the trials under-reported serious complications; and that abortionists were not following the FDA's requirements in administering it.

CWA said the FDA did not respond to its "citizen petition."

"When women's lives are at stake, this is unacceptable," Wright said. "While the label changes implicitly admit the dangerous nature of the drug, trusting abortionists to follow the warnings is a futile effort and does nothing to make the drug itself safe."

Drug-induced abortions 'safe and effective'

Planned Parenthood said it supports the updated mifepristone labeling - "because it is based on the best scientific information available."

Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, said in a press release, "At Planned Parenthood, our number one priority is the health and safety of our patients and we support responsible safeguards for women's health."

Cullins insisted that abortions produced by RU-486 are "extremely safe and effective," and that the medication was approved by the FDA after a "rigorous scientific screening process."

"More than a million women worldwide have used medication abortion safely," Cullins said. "Since it was approved by the FDA in September. 2001, women and doctors nationwide report high levels of success and satisfaction with this early abortion option."

She added that Planned Parenthood's abortion clients receive "extensive education and counseling on what to expect and whom to call with any concerns, 24 hours a day, seven days a week."

See Earlier Stories:
Congressmen Seek Suspension of Abortion Drug (7 Nov. 2003)
Pro-Lifers Criticize FDA for Poor Monitoring of RU-486 (26 Sept. 2003)

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