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Roche Holding AG have written to to health professionals to warn of deaths among patients taking flu drug Tamiflu.
Prescribing information for Tamiflu (oseltamivir phosphate) has been amended to reflect recommendations made by the US FDA Pediatric Advisory Committee on reported paediatric deaths, serious skin reactions, and neuropsychiatric events. These events were reported almost entirely in children from Japan. The letter from Roche notes that these reports are not common.
The data show that these neuropsychiatric adverse events have occurred in flu patients not taking Tamiflu, and there is no evidence suggesting a causal relationship with the drug.
Roche agrees that it is important that healthcare professionals and patients know that all children with flu should be monitored, regardless of whether they are taking an antiviral medication..
Tamiflu has been used by more than 48 million people worldwide, including nearly 21 million children, since its approval in 1999. The FDA have approved Tamiflu for treatment of uncomplicated influenza A and B in patients one year of age or older, and for prevention of influenza in people 13 years or older.