The U.S. Food and Drug Administration Monday urged adding a new warning for the flu drug Tamiflu amid reports of psychiatric problems in patients who take it.
“It is still unclear whether these neuropsychiatric events are drug-related only, disease manifestation alone, or a combination of drug-disease expression,” said an FDA staff summary posted on the agency’s Web site.
The FDA reviewers said they evaluated 103 reports of hallucinations, suicidal behavior and other mental problems mostly among children from August 2005 to July 2006. Three deaths were from falls.
Nearly all the cases, 95 out of 103, came from Japan, the FDA staff said.
Tamiflu was prescribed 24.5 million times in Japan between 2001 and 2005, compared with 6.5 million times in the United States, which has more than twice the population, the FDA Web site said.
Tamiflu is made by the Swiss pharmaceutical company Roche Holding AG, which has discussed label changes with the FDA, a company spokesman said.