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” for those taking mifepristone. That includes 72 users who needed blood transfusions. The FDA requires manufacturers to submit reports of adverse effects if there is “a reasonable possibility that the drug caused the adverse experience.”
In 2001, U.S. Sen. David Vitter, a Republican from Louisiana who was then a U.S. representative, introduced a bill to place restrictions on mifepristone. “I would like to shelve the drug,” Vitter said. “If that cannot be done, at least additional safety measures for women need to be adopted.”
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Related Elsewhere:
The FDA’s page on mifepristone includes its latest statement and much background information.
Last month, the parents of a woman who died after taking mifepristone sued Danco Laboratories.
Earlier Christianity Today coverage of RU-486 includes:
Bitter Pills | What does RU-486 change about abortion? A Christianity Today editorial. (Dec. 11, 2000)
Abortion Pill Critic Named to Drug Panel | David Hager appointed to committee despite criticism from prochoice camps (Feb. 13, 2003)
FDA Candidate Irks Abortion Pill Advocates | The Christian Medical Association says critics fear David Hager’s “well-grounded” opposition. (Nov. 26, 2002)
RU-486 Deaths Prompt Outcry | Danco Labs warns doctors about dangers of ‘early option’ pill (May 24, 2002)
Doctors Slow to Prescribe Abortion Pill | Since RU-486’s approval, rising safety concerns and common side effects have led to little use (Oct. 31, 2001)
Counteroffensive Launched on RU-486 | Abortion-pill critics allege safety concerns overlooked in FDA approval process. (June 15, 2001)
RU-486 Uncovers a Lie—And It’s Not Just About Abortion | Think the abortion pill is indicative of postmodernity? You’re wrong. (Oct. 2, 2000)
Abortion Pill Seems on Fast Track (Sep. 16, 1996)
