BERGEN COUNTY RIGHT TO LIFE

FDA strengthened warning of RU-486

In November, the U.S. Food and Drug Administration (FDA) strengthened the warning label for the abortion drug known as RU-486 or mifepristone.

Although the FDA has linked three deaths to the pill since its approval in 2000, the agency has not yet removed the drug from the market. Federal regulators have received 676 reports of problems with the drug, including 17 ectopic pregnancies, 72 cases of severe blood loss, and 7 cases of serious infection.

As a result of the FDA move, the abortion drug will now carry prominent warnings of the risk of sepsis, bacterial infection, ectopic pregnancy and bleeding. Additionally, physician medication guides have been revised to more clearly identify the risks of mifepristone.

The FDA statement (11/15/2004) concludes: "The revised labeling will provide physicians and patients with important information so that they can respond and possibly prevent rare but serious complications that may occur with any abortion."