FDA to Study Hepatitis B Drug Blamed in Deaths
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WASHINGTON — Federal drug safety officials Wednesday opened a formal review of an experimental hepatitis B drug that is blamed for two deaths and the hospitalization of nine other people.
Food and Drug Administration spokeswoman Monica Revelle said that the agency is examining all the information available on Eli Lilly & Co.’s fialuridine, a drug that had been highly promising as a cure for the virus.
Lilly suspended the tests in patients June 30 after several participants reported serious reactions that required hospitalization.
One patient died Tuesday at the University of Virginia and another had died Monday at the University of Pittsburgh Medical Center.
A third patient, a woman, was in critical condition at the University of Virginia hospital in Charlottesville and was on a list for a liver transplant.
Lilly’s vice president of research laboratories, Dr. Allan Weinstein, said the researchers were surprised by the serious adverse reactions because the drug had been extremely safe and effective in earlier tests on nearly 70 patients.
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