Pro-life Groups say FDA's Label Warnings on Mifeprex Not Enough
Groups say the abortion drug Mifeprex or RU-486 is no less dangerous despite a newly revised warning label of the drug's negative side effects.
The Food and Drug Administration announced Tuesday that a revised warning label listing bacterial infections and bleeding as adverse side effects to the abortion drug Mifeprex will be added to provide users “with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion.” Pro-life groups and others say the label is not enough and want the FDA to pull the drug off the market.
The new label was issued after the FDA and Danco Laboratories, the drug’s manufacturer, received over 676 reports of “adverse events” linked to the drug since its approval in 2000 including the widely publicized death of Holly Patterson, who died in 2003 after using Mifeprex from sepsis.
Mifeprex, also known as RU-486, now carries warnings on the drug’s already “black box” label the agency’s most strident alert, of the drug’s negative side effects including serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death.
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However, since Patterson’s death, the deaths of two more women have been linked to the drug.
Wendy Wright, senior policy director of Concerned Women for America, is calling the FDA to remove the drug, saying the label is inadequate.
“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? How many more women must die before the FDA acknowledges the perilous realities of this drug and removes it from the market?” asked Wright.
Mifeprex is used to end a pregnancy less than seven weeks after conception by blocking a hormone that allows the embryo from attaching itself to the lining of the uterus. Another drug is usually prescribed following Mifeprex in order to expel the remains.
Monty Patterson, Holly’s father, called the revised label “a step in the right direction” but still agreed it is not far enough for the drug to remain available.
Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, stood by the drug she called “safe and effective.”
“More than a million women worldwide have used medication abortion safely," Cullins said in a press release. "Since it was approved by the FDA in September. 2001, women and doctors nationwide report high levels of success and satisfaction with this early abortion option."
"All of us need to understand that no procedure, no medication is risk-free,” she said in an AP article.
But is it is the procedure which Wright has a problem with.
“When Holly Patterson died in September 2003 from using RU-486, after Concerned Women for America had filed extensive e-reported serious complications, and that vidence with the FDA showing the drug was not adequately tested, that the trials under abortionists were not following the FDA’s requirements in administering it, the FDA did not respond. But now, the FDA has resorted to merely changing the label information,” Wright explained.
“When women’s lives are at stake, this is unacceptable,” she said. “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.”
Dr. Pia de Solenni, Director of Life and Women's Issues with Family Research Council, said the “American women have been denied the truth about this drug” and had their lives “placed in jeopardy, because the approval process for RU-486 was short-circuited due to political motivations.”
Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, told AP that making the drug available was “a science-based decision."
A spokeswoman for the Pro-Life Secretariat of the United States Conference of Catholic Bishops noted that a law to suspend approval of RU-486 pending an investigation of its safety has not been voted on but the FDA has not suspended approval of the drug. “Holly’s Law” was introduced by U.S. Representative Jim DeMint (R-S.C.) and Senator Sam Brownback (R-KS) last year.
"RU-486 was the new 'magic pill' to make babies disappear, and young women are now its latest victims," said Cathy Cleaver Ruse, Esq. "RU-486 must be stopped.”
Solenni agreed. "The protection of innocent human life as well as the safety and health of American women must be first and foremost in the FDA's approval process.”
