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2012;32(1):e711

For example, the makers of Tamiflu, Hoffman-La Roche (held by Roche), published their assessment in Drug Safety , which concluded that "the available data do not suggest that the incidence of neuropsychiatric adverse events in influenza patients receiving oseltamivir is higher than in those who do not, and no mechanism by which oseltamivir or oseltamivir carboxylate could cause or worsen such events could be identified." The events in Japan also motivated the FDA to conduct a safety review of Tamiflu and conclude the following: Review of the available information on the safety of Tamiflu in pediatric patients suggests that the increased reports of neuropsychiatric events in Japanese children are most likely related to an increased awareness of influenza-associated encephalopathy, increased access to Tamiflu in that population, and a coincident period of intensive monitoring adverse events

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Joesph Breen said RECOVER-TLC originally planned for at least two large pivotal trials and then at least four [smaller] mechanistic studies