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Adverse Drug Reactions
Roche Statement Regarding Tamiflu U.S. Label Revision
March 23rd, 2008
Roche has informed healthcare professionals that the prescribing information for Tamiflu (oseltamivir phosphate) has been updated to reflect recommendations made by the FDA Pediatric Advisory Committee at a November 27, 2007 meeting regarding neuropsychiatric events. The revision is an update to a label change made in November of 2006 and includes information that influenza itself has been associated with a variety of neuropsychiatric events and that these reports appear to be uncommon. The changes to the label reflect observations from a growing body of data, which shows no evidence of a causal relationship between Tamiflu and the reported events. The data shows that...
Source: Pharma Investments, Ventures & Law Weekly (2008-03-23)
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