Warning issued over a type of blood plasma; six liver transplant patients died in Los Angeles
Friday, May 10th 2002, 12:00 am
News On 6
LOS ANGELES (AP) _ A company that manufactures a form of blood plasma issued a warning years after six liver transplant patients who received the plasma died.
Six of 31 or 32 liver transplant patients at Cedars-Sinai Medical Center died between April and December 1999, the Los Angeles Times reported Friday. But V.I. Technologies Inc. did not issue a warning to doctors and health care providers until two months ago, the Times said.
Hospital officials did not tell the patients' families about the possible effects of the plasma until this week after Newsday, the newspaper based on New York's Long Island, first reported the deaths, hospital spokeswoman Grace Cheng said.
V.I. Technologies, based in Massachusetts, first advised doctors in October 2000 of a possible connection between the deaths and the plasma, which was distributed by the American Red Cross.
The company did not issue a warning until March after four more deaths were reported to the U.S. Food and Drug Administration's national safety-reporting clearinghouse, MedWatch. Those deaths occurred between August 2000 and March 2001 at various hospitals, FDA officials said.
Federal officials began investigating the Cedars-Sinai deaths in 1999.
``We conducted an epidemiological survey and asked: Is this occurring in only one hospital?'' said Dr. Mark Weinstein, one of the leaders of the FDA investigation. ``We don't have a true absolute cause and effect relationship between use of this product and the particular event.''
Cedars-Sinai suspended the use of the plasma in 1999 after it alerted the FDA and the U.S. Centers for Disease Control and Prevention about the deaths. The patients, who ranged from a pregnant 17-year-old girl to a 64-year-old woman, died from unusual clotting or excessive bleeding. Cheng said the patients who died were seriously ill with ``a lot of complications.''
A CDC report released last year found ``no direct cause and effect'' between the plasma and the patients' deaths, but concluded that there may have been a correlation.
V.I. Technologies stopped manufacturing the plasma after divesting one of its divisions to Precision Pharma of Melville, N.Y. That company also does not make the plasma.
Many hospitals continue to use the plasma.