FDA Claims Dangerous RU 486 Abortion Drug Safe Enough For Market

National   |   Steven Ertelt   |   Nov 16, 2004   |   9:00AM   |   WASHINGTON, DC

FDA Claims Dangerous RU 486 Abortion Drug Safe Enough For Market Email this article
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by Steven Ertelt
LifeNews.com Editor
November 16, 2004

Washington, DC (LifeNews.com) — Despite calls from pro-life groups and the father of a California teenager who died after using the dangerous RU 486 abortion drug to take it off the market, FDA officials claim the drug is safe enough to continue to be sold.

Dr. Steven Galson, the acting director of the FDA’s Center for Drug Evaluation and Research, told the Associated Press, "We are concerned about any drug that is related to serious medical complications and, certainly, death."

However, Galson said abortion carries risks such as infection, bleeding or death whether caused chemically or performed surgically. Galson indicated those risks are not sufficient to ban the use of the RU 486 abortion drug, sold under the name Mifeprex.

"We feel that the safety profile of this drug, along with the steps that we’re taking … are adequate to allow the drug to be used safely," Galson told AP.

The FDA has received 676 reports of negative side effects including three deaths, some 17 potentially fatal ectopic pregnancies, and seven women had serious infections like the one that led to the death of Holly Patterson.

Numerous women felt sick and dizzy enough to require hospitalization and another 72 women bled so severely after using the abortion drug that they required transfusions

The FDA on Monday announced that the abortion drug will carry a revised warning label that will tell women considering using it that infections can bring about the death of a woman using the abortion drug.

The drug already carried the Food and Drug Administration’s highest level black box warning — which warns consumers that it is especially dangerous. The labels now warn that serious infection can result without the usual telltale signs like fever or tenderness.

Kurt Entsminger, the president of Care Net, a national network of pregnancy centers, called the revised FDA warning label a "small step in the right direction, but clearly not far enough."

"The FDA’s casual approach to a potentially deadly drug is an affront to women," Entsminger said. "We urge them to immediately suspend the drug and require a thorough review of its safety and long-term impact on women’s health and future fertility."

Entsminger urged Congress to pass the RU-486 Suspension and Review Act, introduced in the House and Senate, which would remove the drug from the market and require the FDA approval process for the drug to be reviewed.

Monty Patterson, the father of California teen Holly Patterson, who died after using the abortion drug she obtained from a Planned Parenthood in San Francisco, said the new FDA warning label was inadequate.

"How many more deaths is it going to take before the FDA takes action to remove this drug from the market?" Patterson asked.

Galson told the Associated Press that the Bush administration had no influence on the decision to expand the warning label.

"There was absolutely no political pressure," he said. "This was a science-based decision."

Related web sites:
Care Net – https://www.care-net.org