EMEA Finds Tamiflu Benefits Outweigh Risks

The European Medicines Agency (EMEA) has issued a statement on the safety of Tamiflu in response to news of neuropsychiatric adverse events reported in connection with the drug in Japan. Overall, the agency said it believes the benefits of Tamiflu outweigh the risks when the product is used according to the adopted recommendations.

The EMEA said its Committee for Medicinal Products for Human Use has closely monitored all adverse drug reactions reported in connection with Tamiflu (oseltamivir phosphate) since it was introduced in the European Union in 2003.

During a recent meeting, the committee recommended that the product information be updated to inform healthcare professionals and patients about possible neuropsychiatric side effects. The recommendation states that patients, especially children and adolescents, should be closely monitored for signs of unusual behavior.

Furthermore, the agency said it will continue to closely monitor any emerging safety information on Tamiflu, including neuropsychiatric disorders.