The maker of a controversial pill used after sexual intercourse to prevent &to=http:// english.pravda.ru/world/2001/03/30/3234.html ' target=_blank>pregnancy - and linked to the death of a California teenager - is adding a new warning to the pill label indicating it can lead to serious bacterial infections.
The Food and Drug Administration sent doctors a letter about the warning for Mifeprex - sometimes called RU-486 - on Nov. 12, saying: "You should be aware of serious and sometimes fatal infections and bleeding that occur rarely following spontaneous (miscarriage), surgical and medical abortions, including following the use of Mifeprex, and &to=http:// english.pravda.ru/fun/2002/04/26/28044.html ' target=_blank>childbirth", Newsday reported.
According to the San Francisco Chronicle, the move was in part a response to the case of an East Bay 18-year-old, Holly Patterson, who died in September 2003 after seeking to end her 7-week pregnancy with RU-486.
In a prepared statement and background information released Monday, the FDA made no mention by name of any case but said the agency had received reports of 676 "adverse events" linked to the drug since its approval in 2000, ranging from minor problems such as nausea to five cases of nonfatal but serious bacterial infection and three deaths.
Two of the deaths resulted from bacterial infections, including the Patterson case and another death that occurred in January 2004 but was not reported to the FDA until August because of some confusion as to what drug had been prescribed.
Another death, in September 2001, followed a ruptured tubal pregnancy, a dangerous condition and a type of pregnancy that RU-486 does not terminate.
Serious bacterial infection may happen silently, without typical signs of infection like fever or tenderness, the label warns. The revised label also cautions health care providers that prolonged, heavy bleeding may warrant surgical intervention.