FDA advisers recently suggested that the world's most widely used flu drug should carry stronger warnings. The current warning label references the fact that there have been reported cases of delirium and self-injury. The panel of advisers suggested that the FDA require the manufacturer, Roche, to include language about recent deaths in Japan based on abnormal behaviors. Five deaths have been reported in Japan after children had been prescribed Tamiflu, the children falling out of windows or running into traffic caused the deaths.

Switzerland based Roche has submitted its own analysis of the data to the FDA which disputes the connection between Tamiflu and the bizarre behavior. In fact, the data seems to suggest that the abnormal behavior appears to be related to the influenza virus itself, not necessarily the medication. The advisory panel has noted that similar deaths have occurred in patients suffering from influenza but not taking Tamiflu.

The FDA advisory panel appears to taking the most conservative approach concerning the warning labels considering the data does not appear to definitively tie the abnormal behavior to Tamiflu specifically. It is understandable in today’s litigious world that the FDA advisory panel would want to take such a conservative approach, but it should be noted that the FDA is not required to follow the suggestions of its advisory panel. Ultimately, it should be up to the manufacturer to determine appropriate warning labels for its own product since the manufacturer holds all liability for the safety of its product.

Since FDA approval is required for all drugs sold in the USA and the FDA can mandate the language required for warning labels, shouldn't they also hold some liability for the safety of the products?