U.S.

Study: Loosen RU-486 Rules

October 17, 2000 / 9:38 PM EDT / CBS/AP

The abortion pill can safely be given a week further along in pregnancy and with fewer doctors' visits than the U.S. government requires, a study funded in part by an abortion rights advocacy group suggests.

The RU-486 regimen approved last month by the Food and Drug Administration "is unnecessarily restrictive and creates scheduling and additional cost barriers to women," the study's authors wrote in Wednesday's Journal of the American Medical Association.

At least three doctors' visits, including a follow-up to make sure the abortion is complete, are required in the FDA-approved process.

In approving RU-486, the FDA said doctors must sign an agreement promising to adhere to the approved regimen and patients must sign a statement saying they will make the necessary doctors' visits.

In addition, the Population Council, which owns U.S. rights to mifepristone, agreed to check to make sure patients and doctors are signing the agreements.

Doctors who are caught not following the regimen could lose their supplies of the drug, according to the FDA.

The study found high success rates with only two visits, which would make the process cheaper and available to many more women. The study was funded in part by the advocacy group Abortion Rights Mobilization.

Under the FDA regimen, women use mifepristone, RU-486's chemical name, within 49 days of their last menstrual period. Mifepristone blocks the action of progesterone, which allows an embryo to develop. Two days later they return to their doctors to take a second medication, misoprostol, under observation. Misoprostol causes contractions that expel the embryo.

Both medications are taken orally in the FDA regimen, which previous studies have found to be between 92 percent and 95 percent effective.

The Entrenched State Laws

The FDA approval of Mifepristone, known here as Mifeprex and formerly known as RU-486, doesn't guarantee quick release of the drug. Many states have laws on the books that will make it difficult for doctors to circulate the drug.

The new study of 2,295 women, led by Dr. Eric A. Schaff, a New York abortion provider and professor at the University of Rochester Medical Center, found success rates of 96 percent to 98 percent. Mifepristone was taken up to 56 days after the ast menstrual period, followed by vaginal misoprostol tablets at home one to three days later.

Thirteen unexpected or serious side effects occurred, including two hospitalizations, for pelvic infections. Other complications included four women treated for either excessive bleeding or vomiting and dehydration.

Spokeswoman Laura Echevarria of the National Right to Life Committee said allowing women to take misoprostol at home without a doctor present is "playing Russian roulette with women's lives."

An FDA representative said the government-approved process is based on studies of safety and effectiveness in the United States and France. To consider changes, the FDA would probably seek more data and the Population Council would have to submit a request.

Dr. George Huggins, chairman of Planned Parenthood's national medical committee, said if Schaff's findings are confirmed in further research, "my expectation would be that people would begin to change the protocol, because it does give more flexibility," better results and better control.

By LINDSEY TANNER