- The Washington Times - Tuesday, November 16, 2004

The FDA said yesterday the abortion pill RU-486 will remain on the market despite criticisms from opponents who want the pill banned because they say three women have died after taking it.

“We feel the safety profiles of this drug are adequate to allow the drug to be used safely. But we’ll continue to monitor it,” said Dr. Steven Galson, acting director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research.

Effective immediately, the drug will carry a “strengthened” black-box warning, advising of risks including death from bacterial infections, septic shock and heavy bleeding. There also is a renewed warning of risks associated with tubal pregnancies.

“We are concerned about any drug that may be related to serious medical complications and death,” Dr. Galson said. “But infections, bleeding and death can result from medical and surgical abortions and even childbirth.”

One of those calling for the removal of RU-486 from the market is Monty Patterson, 51, of Livermore, Calif. His 18-year-old daughter, Holly, died of septic shock caused by inflammation of the uterus seven days after she took RU-486 to end a pregnancy last year.

“My wife, Helen, and I are pleased that the FDA is adding new black-box warnings,” Mr. Patterson said. But he added that it wasn’t enough.

At a press briefing yesterday, Dr. Galson discussed the deaths of three American women who took RU-486. He said the deaths occurred between October 2001 and January 2004.

The first woman’s death occurred after a ruptured tubal pregnancy. She had been given RU-486, even though the drug does not terminate that type of pregnancy.

Miss Patterson’s death occurred in September 2003. The FDA said it was not until August this year that it learned of the death of another young woman in January. Like Miss Patterson, that woman died of a bacterial infection.

“We’ve investigated the three deaths and don’t have information to know that the drug caused the events,” Dr. Galson said.

The drug in question, approved by the FDA in 2000, is known generically as mifepristone. It is manufactured by Danco Laboratories of New York, and its trade name is Mifeprex.

It has been taken by about 360,000 women in the United States since its approval.

“We’ve received 600 reports overall” of adverse events involving people who have taken the drug, Dr. Galson said.

He said Mifeprex already bore a “black-box” warning — the FDA’s strongest safety alert — on its label.

In August 2002, three groups — Concerned Women for America (CWA), the Christian Medical Association and the American Association of Pro-Life Gynecologists — filed a petition with the FDA, requesting the withdrawal of RU-486 because of safety concerns.

Yesterday, Wendy Wright, spokeswoman for CWA, said she was puzzled by the FDA’s refusal to say Miss Patterson’s death was caused by the abortion drug.

“The coroner’s report said her death was caused by a drug-induced abortion, so there clearly was a relationship.”

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