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Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012
Publications from Roche and a case-control study suggest that there is no evidence, or plausible mechanism of action, to link neuropsychiatric adverseeventst oTamiflu (oseltamivir). Cochrane Collaborators, the BMJ ,and others,however, contend that many of Roche’s data remain unavailable.
We examined neuropsychiatrica dverseevents associated with oseltamivir in the USFDA’s Adverse Event Reporting System (FAERS) from October 1999 to August 2012 by using a data mining platform (RxFilterTM) to generate case report counts and reporting ratios for multiple MedDRA (Medical Dictionary for Regulatory Activities) categories, including those queried in the Roche papers.
Reporting odds ratios were calculated using standard methods, but numerator and denominator variables were constrained to the period of time beginning with oseltamivir’s FDA approval date and ending with themostrecent FAERS data.