- The Washington Times - Thursday, August 22, 2002

Two medical associations and a women's group have asked the Food and Drug Administration to revoke its approval of the chemical abortion drug Mifeprex and halt the drug's distribution.

"We have discovered some startling facts concerning RU-486 two women are dead, one 21-year-old girl suffered a heart attack and two 15-year-old girls have suffered life-threatening infections," said Sandy Rios, president of Concerned Women for America (CWA).

The FDA ignored its safety and validation procedures to approve Mifeprex on Sept. 28, 2000, perhaps because of the urging of President Clinton and Health and Human Services Secretary Donna E. Shalala, said Mrs. Rios, who called for an audit of the research that led to FDA approval of the drug.

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"To safeguard the health of American women, this drug must be removed from the market," said Dr. Donna J. Harrison, a leader of the American Association of Pro-Life Obstetricians and Gynecologists, which joined with the CWA and the Christian Medical Association in filing the 92-page petition Tuesday.

An FDA spokesman said yesterday he could not confirm that the agency had received the document. However, the FDA gets about 300 "citizen petitions" a year, "and the goal is to respond to them in 180 days," he said.

Mifeprex is manufactured by New York City-based Danco Laboratories and is being marketed as "the early option pill" a safe and effective way to end a pregnancy without surgery.

Women who have been pregnant seven weeks or less can obtain the two-drug (mifepristone and misoprostol) chemical abortion process from their doctors or clinics. The miscarriage-like abortion may occur at home, with bleeding and cramping a "normal part of the process," according to Mifeprex materials.

Side effects include nausea, headache, vomiting, diarrhea, dizziness, fatigue and back pain.

Dr. Harrison said she expects Health and Human Services Secretary Tommy G. Thompson to take the petition seriously.

During his 2001 nomination hearings, "he said if we show that there are safety concerns with this drug, he would re-evaluate, and that's what we've done. And we do expect that Mr. Thompson will honor his word," she said.

The two deaths and three hospitalizations are described in an April 19 letter Danco wrote to health care providers. The letter is posted on the FDA Web site.

Danco said it had received "a small number of reports of ruptured ectopic pregnancies," including one that ended in death, "two cases of serious systemic bacterial infection (one fatal)" and a heart attack that have occurred among Mifeprex users.

Mifeprex is "not an effective treatment" for the 2 percent of pregnancies that occur outside the uterus, Danco reminded doctors in its letter.

In addition, it said, "although serious infection in medical abortion is rare, we ask that you be alert to this possibility if your patients report symptoms or have signs of infection."

"No causal relationship between any of these events and use of Mifeprex and misoprostol has been established," the company said in its letter.

Mrs. Rios and her colleagues said the two deaths and the three hospitalizations were the most serious episodes of many health problems they found after combing through 8,000 documents on Mifeprex.

But a spokeswoman for Danco said the company is not concerned by the petition. "We have followed all the FDA guidelines and provided them with all the information, and we feel very comfortable with the FDA process," she said.

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