November 22, 2004
Volume 6 / Number 36
The FDA rushed to approve the abortion pill under special rules a few years ago, and now it has decided to warn women of the drug’s fatal potential for them.
Steven W. Mosher
The Abortion Pill Can Kill Mothers, Too
The federal Food and Drug Administration (FDA) approved RU-486, or mifepristone, under special expedited rules in 2000 during the Clinton Administration, and on Nov. 15, 2004, it decided to emphasize the possibly deadly consequences of taking it-not for unborn children, but for mothers. As a byproduct of killing her child, the drug can also kill the woman who chose to take it.
“The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC’s labeling of mifepristone (trade name Mifeprex, also known as RU-486),” said the FDA in a press release on November 15. “Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA.”
These reports of serious side effects, even death, have been accumulating for years. The wording of the FDA release was careful not to suggest that RU-486 is any more dangerous than other methods of abortion: “The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all.”
Earlier this year, Monty Patterson, the father of Holly Patterson, met with officials at the FDA and the White House about the fate of his daughter. The 18-year-old California girl died last year after taking RU-486 despite obeying her abortionist’s instructions, and despite having no underlying health problems.
House Republicans including Rep. Roscoe Bartlett (Md.) plan to reintroduce a bill to ban the sale of mifepristone. At least three American women have died after taking the abortion pill, but since reports of adverse drug effects are not necessarily made public and America’s reporting system is spotty anyway, no one knows how many women have been killed by RU-486. But we do know that the FDA has received 676 adverse effects reports.
The president of the country’s largest network of crisis pregnancy centers, Care Net, says that the drug should be banned. “If consumers are suffering and even dying, additional small print on a piece of paper is not the answer,” Kurt Entsminger said the day after the FDA decision. In addition, the FDA did not address abortionists’ common usage of mifepristone in dosages and combinations different from that approved by the agency. Although such practices are legal-doctors may prescribe drugs any way they please once they have been approved-Monty Patterson and others say they are not safe.
Will the Bush Administration ever reverse the hasty approval of RU-486? Or will Congress, controlled by an officially pro-life party, ever work up the courage to ban it?
Joseph A. D’Agostino is Vice President for Communications at the Population Research Institute.