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National NOW Times >> Winter 2004/2005 >> Article

FDA Strengthens Mifepristone Warning, Based on Science or Anti-Choice Bias?

by Leanne Libert, Managing Editor

The U.S. Food and Drug Administration announced Nov. 15 they would strengthen the "black box" warning on mifepristone, the abortion pill also known as RU-486, after reports of infection, bleeding and only a few deaths in women who used the drug.

Yet, in the four years, mifepristone has been prescribed in the U.S., only two deaths have been indirectly linked to its use. This "revision" of mifepristone's warning label says more about the FDA's gross inconsistencies and conservative bias, than its desire to protect the lives of women.

Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency received "absolutely no political pressure" from the Bush administration. He called the label revision "a science-based decision."

What science does Dr. Galson study? Is it the science that hailed Vioxx as the best pain reliever on the market when it actually doubled the risk of heart attack and stroke in patients?

Was it the science the FDA used to reconsider allowing silicone breast implants, associated with higher risk of some cancers, back into plastic surgeon's operating rooms without adequate testing?

Mifepristone is safer than many prescription and over-the-counter drugs people use in the U.S. every day, yet the FDA feels the need to strengthen an already intense warning on the drug.

Tylenol—"recommended by doctors more than any other pain reliever" as their ads declare—causes 150 deaths each year.

Viagra has been associated with several hundred heart attacks and several scores of deaths. Mifepristone has been used by approximately 360,000 women in the U.S. to induce an abortion in early pregnancy as a medical alternative to aspiration (suction) abortion. Since 2004, the FDA received only 676 reports of adverse effects from women who used the drug, including two deaths from bacterial infections, according to San Francisco Chronicle, Nov. 16.

In fact, 97 percent of women who chose mifepristone for medical abortion would recommend it to a friend, and since 1991, only six deaths have been reported among the more than one million women who have been treated with mifepristone worldwide, according to a study released by PPFA. If this drug is safe, what's the problem?

The problem lies in the ultra-conservative, anti-choice administration running this country. They will stop at nothing to limit a woman's right to choose—a common theme in much of their decision making.

The Bush administration pushed for the Partial Birth Abortion Ban, reinstated the global gag rule which cuts funds to family planning programs around the world, stopped emergency contraception from being sold over the counter and most recently the Federal Refusal Clause which takes choice out of the woman's hands and gives it to insurance companies.

We expect the fight to protect women's reproductive rights to continue and worsen over the next four years, but we're ready. We will never give up.

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