FDA Issues Health Warning After Reports of Abortion Pill Deaths

By Patrick Goodenough | July 7, 2008 | 8:05 PM EDT

(CNSNews.com) - The maker of an abortion pill has reported the deaths of five American women after taking the drug. This is the same pill that the U.N.'s key health agency recently added to its list of "essential medicines."

The news prompted the Food and Drug Administration to issue a public health advisory and pro-lifers to renew their calls for authorities to outlaw mifepristone, the drug marketed in America as Mifeprex, and also known as RU-486.

Mifeprex manufacturer Danco Laboratories issued a statement saying that in the almost five years the drug has been available, it has received reports of five deaths from serious bacterial infection and sepsis, following use of Mifeprex and its partner drug, misoprostol.

One woman died in Canada during a clinical trial in 2001, and four others in California between late 2003 and mid-2005.

Danco medical director Richard Hausknecht said "no causal relationship" had been established between the deaths and use of the drugs, but Danco was modifying labeling to include updated safety information.

Women using the drugs should seek immediate medical help if they experience abdominal pain or discomfort, weakness, nausea, vomiting or diarrhea, the statement said.

Danco also reported that since the FDA approved the drug in September 2000, more than 460,000 women had used them to end pregnancies.

In contrast to a surgical abortion, a "medical" abortion comprises a dose of mifepristone, followed 48 hours later by misoprostol. The regimen is reported to be more than 98 percent effective in destroying a baby in the womb up to two months after conception.

"Childbirth, menstruation and abortion, whether spontaneous, surgical or medical, all create conditions that can result in serious and sometimes fatal infection, and there is no evidence that Mifeprex and misoprostol present a special risk of infection," Danco said.

The online medical news service MedPage Today quoted American College of Obstetricians and Gynecologists (ACOG) spokesman Dr. Steven Sondheimer as saying that with 460,000 women having used the drug since 2000, "it appears to be safe."

The small risk of bleeding and infection associated with medical and surgical abortion is less than that associated with pregnancy, said Sondheimer, a professor of obstetrics and gynecology at the University of Pennsylvania's medical school.

Nonetheless, the FDA Tuesday reacted to Danco's statement by issuing a new public health advisory highlighting the risks.

""The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with healthcare providers and patients the latest serious reports of infection associated with this drug that we have received," said Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research.

This is not the first time the FDA has drawn attention to problems associated with mifepristone.

Late last year it ordered revised labels for the drug, after receiving "reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death."

Recently, the U.N. World Health Organization added mifepristone and misoprostol to its list of "essential medicines," following a period of lobbying from groups on both sides of the abortion debate.

Supporters of the drug said making it more easily available, especially in the developing world, would reduce the number of women dying each year as a result of "unsafe" abortions.

Pro-lifers reject the notion that any abortion can be "safe," given the destruction of the unborn child. Campaigners also charge that women having abortions themselves risk physical or emotional harm.

Reacting to Danco's announcement, American Life League president Judie Brown said the reported deaths provided "further evidence of the abortion industry's pursuit of a reckless path of destruction that leaves millions of victims dead in its wake."

"How many more women and preborn children must die before this lethal drug is taken off of the market?"

Brown said the drug had no beneficial qualities, its sole purpose being "to end the life of a preborn child."

Updating warning labels would do nothing to prevent more deaths, she argued. "These reports of tragic deaths will not cease until this deadly drug is no longer available."

See also:
UN Health Agency Adds Abortion Drugs to 'Essential Medicines' List (Jul. 11, 2005)

Send a Letter to the Editor about this article.

Patrick Goodenough
Patrick Goodenough
Spencer Journalism Fellow