Responding to another death linked to the abortion-inducing pill formerly known as RU-486, the Food and Drug Administration (FDA) has strengthened its "black box" warning on the drug. Three deaths, the latest from septic shock, have been linked to its use.
Danco Laboratories is the sole U.S. distributor of mifepristone, known by its trade name, Mifeprex. The black box label warns about the possibility of infection and sepsis, vaginal bleeding, ectopic pregnancy, and death. It is the FDA's strongest label, also used on some antidepressants, for example.
David Stevens, executive director of the Christian Medical Association (CMA), maintains that the FDA failed to follow standard procedural and scientific requirements to ensure the safety and efficacy of mifepristone. Stevens believes that "the testing was accelerated for political reasons." The FDA has recently been faulted for rushing other drugs to market, like Vioxx, which it recently withdrew after public concerns.
The CMA, along with Concerned Women for America and the American Association of Pro-Life Obstetricians and Gynecologists, filed a 90-page citizens' petition in August 2002. In it they asked the FDA to rescind its approval and put ru-486 through more rigorous testing.
Cynthia Summers, Danco Laboratories spokeswoman, said more than 2,000 women used Mifeprex in clinical trials and more than 360,000 have used it since the FDA's approval in September 2000. "Mifeprex underwent rigorous testing and review before being approved by the FDA," Summers said. She noted that the FDA has found no causal relationship between the three deaths and the use of Mifeprex.
The FDA concedes that since the drug went on the market through November 5 there have been 676 "adverse events" ...1