FDA Recommends Warning on Tamiflu Label
Posted on: Tuesday, 14 November 2006, 12:01 CST
US health authorities have recommended adding a new warning to the label of Roche's influenza drug Tamiflu after reports of psychiatric side effects from patients taking the drug.
The FDA said they reviewed 103 psychiatric reports including suicidal behaviour from August 2005 to July 2006. Three deaths were recorded in the reports. Most of the events occurred in Japan.
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 said.
"It is still unclear whether these neuropsychiatric events are drug-related only, disease manifestation alone, or a combination of drug-disease expression," FDA staff said.
An advisory committee had previously decided no labelling changes were needed. Tamiflu could be used in the event of an avian influenza outbreak.
Source: Datamonitor
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