New Warnings Following RU486 Death

Marketed as Mifeprex, the drug already carried the Food and Drug Administration's highest level black box warning -- which warns consumers that it is especially dangerous.

The black box warning will expand and include new information on dangers that could cost women's lives, such as information on life-threatening complications like severe bacterial infections that led to the September 2003 death of Holly Patterson.

The new warning labels also discuss the extensive bleeding that can occur following a chemical abortion, as can happen with any abortion.

The labels warn that serious infection can result without the usual telltale signs like fever or tenderness.

Following approval by the Clinton administration in 2000, the FDA has received numerous reports of complications resulting from the use of the abortion drug.

"FDA and (drug maker) Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis (blood infection) that was recently reported to FDA," the agency said in a statement.

"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," the FDA said.

A representative of Concerned Women for America blasted the decision, saying the warning labels don't make the drug safer and that the agency should prevent abortion businesses from selling the dangerous drug.

"It is reported that another woman has died after taking the abortion drug RU-486, and the FDA's response is to change the drug's label," Wendy Wright, the group's senior policy director, said in a statement. "This is a dangerous drug that deserves to be pulled off the market immediately."

The FDA "will continue to monitor the usage of Mifeprex and may take further action," the federal agency added.

Patterson died after taking the Mifeprex abortion drug given to her by a Planned Parenthood facility near San Francisco. An autopsy report shows Holly died of an infection brought on by the abortion.

In February, the California Department of Health Services determined that Planned Parenthood failed to follow its own internal policies for informing women on how to use the RU 486 abortion drug that was responsible for Holly's death.

The abortion business has also been accused of not following FDA protocols, including using wrong doses of the abortion drug and misusing an ulcer drug to cause a miscarriage of the dead baby.

Searle, the maker of the ulcer drug, issued a nationwide letter to doctors saying it is not intended to produce an abortion and using it as such places women's health at risk.

Monty Patterson, Holly's father, met in September with FDA officials this week to discuss stronger enforcement of safety regulations.

Patterson said he hoped to bump up the level of safety standards required of abortion facilities that distribute the two-part abortion drug. He also asked the FDA to require abortion practitioners and businesses to report any adverse side effects of women using the abortion drug to the agency.

In response to Holly's death, Monty and Helen Patterson endorsed Congressional legislation, tentatively called "Holly's bill," that would suspend the FDA's approval of the drug pending a Congressional review.