Warning Issued About Abortion Drug may Negate FDA Approval of RU-486

      GAINESVILLE, Fla. -- Supporters of the abortion pill mifepristone, or RU-486, which is set to be released in several weeks, cannot celebrate the drug''s approval by the Food and Drug Administration just yet.

      G.D. Searle, the drug manufacturer of Cytotec, the trade name for misoprostol, issued a letter in August warning physicians against the use of the drug for pregnant women six weeks before the approval of RU-486, Searle spokeswoman Mary Boegeli said.

      Misoprostol is the second drug used in the nonsurgical abortion procedure.

      Boegeli said Searle never intended the use of Cytotec for pregnant women and have never completed clinical trials for that purpose.

      In effect, this warning renders the Sept. 28 FDA approval of mifepristone useless. In response to this warning, Okla. Rep. Tom Coburn and Ark. Sen. Tim Hutchinson introduced bills on Oct. 4 that would restrict the use of mifepristone in combination with misoprostol.

      The two bills, known as the RU-486 Patient Health and Safety Protection Act, also support further restrictions on RU-486 - restrictions the FDA rejected when it approved the drug. Those who support the pill and the FDA''s approval opposed the congressmen''s legislation.

      The American College of Obstetricians and Gynecologists sent a letter on Oct. 11 to Coburn and Hutchinson opposing their bills. According to the letter, the ACOG''s Committee on Obstetric Practice "reviewed the FDA data on adverse effects and other available scientific and clinical data in light of Searle''s warning" but still supports its use in these procedures.

      Lisa Radelet, spokeswoman for North Central Florida Planned Parenthood, said that misoprostol was safe and effective in FDA studies.

      "The experience of more than 1,000 women in the United States during clinical trials is what the FDA based its approval on," Radelet said. "Right now, there is nothing to contradict that, but maybe we will have to start looking for another alternative for the second drug."

      Searle warned physicians not to use misoprostol in pregnant women at all because it may cause uterine ruptures or death, Boegeli said.

      Since the warning, half of the nation''s hospitals have stopped using Cytotec. Hospitals fear that the warning letter will open the door for possible litigation against physicians who continue its use.

      Radelet said she only can speculate, but Searle may be trying to separate itself from the abortion controversy. The company also may be responding to intimidation by anti-abortion groups, she said.

      Boegeli denied those speculations, saying the change is only a revision of product information.

      The University of Florida Student Health Care Center has no plans to make this procedure available on campus. Instead, UF will offer information and referrals for the procedure.

      Other universities around the state, including Florida State University and Florida Atlantic University, have said they would not carry the drug.

      When asked if UF does not plan to provide mifepristone because it is afraid of unwanted controversy, Joanne Auth, coordinator of education and training programs at the Infirmary, said, "Who isn''t?"

      UF has to decide whether the number of requests for RU-486 and the costs of the needed equipment would be a feasible trade-off.

      The Infirmary offers regular and emergency contraceptives. Between 400 and 500 emergency contraceptives were requested last year. UF has not closed the door on making the new abortion pill available in the future.

      Auth said the Infirmary and its director, Dr. Phillip Barkley, welcome comments and questions about the pill.