676 "adverse events" reported; FDA Heightens Abortion Pill Warning After Latest RU486 Patient Death.

On the heels of the revelation of yet another death of a woman who took RU486, the abortion pill's U.S. distributor has sent warnings to emergency rooms and the U.S. Food and Drug Administration (FDA) has decided to beef up the warning label on the abortion pill.

This latest reported death of an American woman brings to eight the number of known deaths worldwide associated RU486. Three of those fatalities have been in the U.S. since the drug was approved for marketing in the United States in September 2000.

Few details are available on the most recent death. One news service (UPI, 11/16/04) identified the victim as a woman from New Jersey, while another news account (NY Times, 11/15/04) called her a "California woman." Accounts appear to converge on the fact that she died in January 2004 of a septic infection which followed her chemical abortion. A coroner's mistake - - identifying a different drug, methotrexate, rather than mifepristone (RU486) as the abortive agent - - delayed its report to the FDA until September.

Following a series of discussions between the FDA and Danco, the abortion pill's U.S. distributor, the "black box" warning on the drug's official label was significantly expanded. Danco also sent warning letters to potentially prescribing "health care professionals" and to emergency room directors who might end up treating complications brought on by the pill and the accompanying prostaglandin (PG) that is used to begin contractions to expel the dead unborn baby.1

Every "successful" RU486/PG abortion involves a fair amount of bleeding, pain, and cramping as the baby is killed and then expelled from the uterus. Side effects such as vomiting, diarrhea, and other forms of gastro-intestinal distress are not uncommon. At issue in the letters and labeling changes are concerns that signs of infection, ectopic pregnancies, or hemorrhaging will be masked by the chemical abortion process so that patients do not seek or receive medical care until it is too late.2

An Expanded "Black Box" and Warning Letters

The new greatly expanded "black box warning" which heads the label warns prescribers, "Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use" ["Mifeprex" is the U.S. trade name for mifepristone]. Prescribers are instructed to tell patients of these risks and to instruct them where to go and what to do if they experience "sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope [fainting]."