WASHINGTON, Nov. 16 (UPI) -- The death of a New Jersey woman along with other complications has prompted regulators to put a stronger warning on the abortion drug RU-486.
The Food and Drug Administration move follows the death of an 18-year-old East Bay woman last year, plus 676 other "adverse reactions" the agency is aware of, the San Francisco Chronicle reported Tuesday.
Although the woman's death was not cited Monday by the FDA, hers was one of three deaths, two of which have resulted from bacterial infection.
New York's Danco Laboratories, the maker of RU-486 in the United States, said it is sending letters to medical providers this week advising them of the changes.
The FDA said it hasn't established whether the abortion pill directly caused any of the so-called adverse events, emphasizing life-threatening complications such as severe bleeding and infection may occur "following any termination of pregnancy," whether by miscarriage, surgical abortion or drug-induced abortion.
RU-486, known generically as mifepristone, is sold in the United States under the brand name Mifeprex, has been used by about 360,000 women in this country since the FDA approved its use in 2000.
