FDA Reaction to Another RU-486 Death: Change the Label

Amidst reports of another young woman's death related to an FDA-approved abortion pill, pro-lifers are again calling for the drug to be pulled from the market. But the federal agency's latest response — adding new warnings to the label — is unacceptable, say critics of the FDA.

California 18-year-old Holly Patterson died in September 2003 after taking RU-486 (also known as “Mifeprex”) to abort her baby. She died of septic shock. Holly, who had obtained the treatment from a Planned Parenthood clinic, was not the first to die after taking the abortion pill manufactured by Danco Laboratories, and to the disappointment of Holly's parents and pro-life groups, she was not the last. The Food and Drug Administration reported last week it had received word of yet another RU-486-related death, again from sepsis.

RU-486 had already carried a “black box” warning, the FDA's most strident alert. Now, according to a statement from the FDA, the new warnings add information on the “risk of serious bacterial infections, sepsis, and bleeding and death that may occur” following any abortion, and reminds health-care providers that “serious bacterial infection and sepsis may occur without the usual signs of infection.” But pro-life groups say simply changing the label is not enough, particularly in light of the fact that abortionists refused to follow the original guidelines.

“Why would anyone think that by the FDA changing words on a label, abortionists will suddenly put women's health and lives above their own convenience and profits?” asks Wendy Wright of Concerned Women for America. “How many more women must die before the FDA acknowledges the perilous realities of this drug and removes it from the market?”

Wright's organization, along with several others, protested the FDA's approval of RU-486 [PDF] in the waning weeks of the second Clinton administration, claiming the trials were tainted and that the agency violated its own regulations in its desire to rush the drug to the market. But the FDA did not respond then, and this latest response, says Wright, falls considerably short.

“When women's lives are at stake; this is unacceptable,” she continues. “While the label changes implicitly admit the dangerous nature of the drug, trusting abortionists to follow the warnings is a futile effort and does nothing to make the drug itself safe. This is a dangerous drug that deserves to be pulled off the market immediately.”

The U.S. Conference of Catholic Bishops could not agree more. A spokesman for that group's pro-life arm is also calling for the drug to be yanked from the market.

“RU-486 doesn't need a better label,” says Cathy Cleaver Ruse. “It needs to be shelved.” And noting that young women depend on the safety of FDA-approved drugs, she adds: “RU-486 was the new 'magic pill' to make babies disappear, and young women are now its latest victims. RU-486 must be stopped.”

The FDA says it will continue to monitor the usage of RU-486 and “may take further action.”

(This article courtesy of Agape Press).

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