A little more than a year after a California teen died following complications resulting from an RU-486 abortion, the Food and Drug Administration will require the “abortion pill” to have labels warning how infections can bring about death.

RU-486, marketed in the United States as Mifeprex, has already been carrying a black box warning, the highest level warning issued by the FDA, alerting consumers that it is especially dangerous. But the black box warning will expand the information provided, including information on its life-threatening complications – such as the severe bacterial infections that led to the September 2003 death of Holly Patterson – and extensive bleeding.

Since the FDA approved the drug in 2000, the federal agency and Danco Labratories, the drug’s American maker, have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured and death. The FDA has also admitted that there was another recent death from sepsis, the kind of blood infection that killed Patterson.

Wendy Wright, senior policy director of Concerned Women for America, said the new FDA regulations don’t make the abortion pill any safer. “This is a dangerous drug that deserves to be pulled off the market immediately,” she said. Others echoed that sentiment: “RU-486 doesn’t need a better label, it needs to be shelved,” said Cathy Cleaver Ruse, a representative of the pro-life office of the U.S. Conference of Catholic Bishops.

Holly Patterson’s parents also said the warning was insufficient to protect women from a drug that is lethal not only to the unborn child, but to women as well. Monty Patterson said, “How many more deaths is it going to take before the FDA takes action to remove this drug from the market?” he said. “I’m not convinced this drug is safe and I still think it should be banned.”

Pro-lifers hope that the FDA’s action will improve chances that a bill introduced last year by Senator Sam Brownback (R, Kansas) and Rep. (and now Senator-elect) Jim DeMint (R, SC) to suspend the drug’s approval pending further study will pass. Dr. Donna J. Harrison, an obstetrician-gynecologist, noted in a New York Times column in November that the FDA originally approved RU-486 by circumventing “five standard procedural and scientific requirements to prove safety and effectiveness.” Harrison said the drug would not have been approved if the FDA used its normal procedures, including the employment of uncontrolled clinical trials and its “accelerated approval regulations” process, which is reserved for case of treatments for life-threatening illnesses.

There are reports of women dying after using RU-486 in Canada, Sweden, the United Kingdom and the United States. Harrison’s Time column revealed that there have also been 676 reported case of serious complications, clearly illustrating the need for the drug’s prohibition.

Little has been made public about clinical trials for RU-486 in Canada since a woman died in September 2001 during those tests.

Currently, RU-486 is not widely marketed in Canada.