Anti-abortion Groups Attack FDA Approval of Mifepristone

Despite substantial evidence showing the health benefits of mifepristone, anti-abortion groups submitted a 90-page petition to the Food and Drug Administration (FDA) asking for the immediate ban of the drug – approved by the FDA in September 2000 for the termination of early pregnancy. The petition, written by Concerned Women for America, the American Association of Pro-Life Obstetricians and Gynecologists and the Christian Medical Association, cites six cases in which women taking Mifeprex suffered complications, as reported by Danco Laboratories, the drug’s manufacturer. The petition also accuses the FDA of rushing mifepristone’s review process – despite the fact that the agency spent four years looking for any potential health risks.

The FDA has taken no action to place additional restrictions on mifepristone. In fact, this petition comes two weeks after the FDA announced that mifepristone has been placed on fast track approval for the treatment of psychotic major depression. A study conducted by researchers at Stanford University found that people who suffer from psychotic major depression were found to improve quickly and with few side effects using mifepristone, also known as RU 486. Doctors and researchers also are discovering other potential uses of mifepristone, including as a possible treatment for uterine fibroids, endometriosis, Cushing’s syndrome and several types of ovarian and breast cancer.

“Besides providing women with a safe and effective early medical abortion, mifepristone has significant implications for improving women’s health in numerous ways,” said Dr. Beth Jordan, a women’s health specialist and medical director for the Feminist Majority Foundation. “It’s high time to stop playing politics and get down to the business of exploring mifepristone’s extraordinary multiple medical potential.”

In the six cases cited by Danco in April, both the FDA and the company noted that no casual relationship has been established between mifepristone and the adverse effects. The six cases they detailed involve three ectopic pregnancies (with one death), one non-fatal heart attack, and two bacterial infections (with one death). More than 1 million women worldwide have used mifepristone and misoprostol in combination for safe and effective early medical abortion with the FDA-approved mifepristone regimen. By comparison, more than 616 deaths have been linked to Viagra – the popular impotency drug for men, according to the Uppsala Monitoring Center, a United Nation’s Collaborating Centre for International Drug Monitoring.


Wall Street Journal 8/21/02; Kaisernetwork.org 8/21/02; Feminist Majority Foundation; www.who-umc.org

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