As flu season rapidly approaches, parents and doctors are being urged to closely monitor children who are taking Tamiflu after reports linking the flu-fighting drug to bizarre psychiatric episodes. According to a newly released review by the Food and Drug Administration, there were more than 100 reports of abnormal behavior–including delirium and suicidal tendencies–in Tamiflu patients between August of 2005 and July of this year. The FDA is considering adding new warnings to the Tamiflu label in order to inform patients of the risks involved.
Tamiflu (oseltamivir phosphate) is made by Roche Pharmaceuticals and was approved by the FDA for use in children aged 1 to 12 in December of 2005. The large majority of the reports of adverse psychiatric effects (including three fatalities) came from Japan, where Tamiflu is incredibly popular.
The FDA’s Pediatric advisory committee will meet Thursday to decide whether to recommend the label change, which would highlight the possibilities of “abnormal behavior†in children. Labels in Japan already reflect the risk of these potentially dangerous psychiatric side effects. At a meeting last year, the advisory committee declined to approve a label change, even after reports had linked Tamiflu to 12 child deaths in Japan since 2000.
The antiviral drug has been closely watched because it has proven to be effective in the treatment of bird flu. (Tamiflu doesn’t prevent a patient from contracting influenza, but it has been shown to significantly lessen the impact of the virus.) In addition, it still is not clear whether these psychiatric effects are related to the drug itself or the virus–or some combination of the two. Yet, the FDA has seen enough evidence linking the drug to abnormal behavior to issue these alerts asking consumers and health-care professionals to be vigilant in observing behavioral changes in youngsters who are taking Tamiflu. The FDA also warns that taking a child off Tamiflu may be equally as dangerous, so they suggest that decisions be made in conjunction with a doctor.
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