Tamiflu

Tamiflu is a prescription influenza medicine used to treat flu symptoms in children and adults. The drug, manufactured by Roche Laboratories Inc., received approval by the Food and Drug Administration in October 1999. Tamiflu is not a substitute for flu vaccination, it works to prevent the influenza virus from spreading.

Tamiflu Side Effects

On November 13th 2006, the Food and Drug Administration (FDA) and Roche Laboratories Inc. issued a notification to doctors suggesting that the drug's prescribing information be revised to include reports of self injury linked to its use.

The notification cautioned of delirium, confusion and risk of self injury in people using Tamiflu, especially children. It also suggested that such patients be closely observed for any signs of abnormal behavior.

Most of the incidents that linked Tamiflu to neuropsychiatric disorders were reported from Japan where, in February 2007, two teenagers were suspected to have committed suicide after taking the medication. Earlier in 2005, 12 other children died in suspected cases of suicide linked to Tamiflu use. There are at least 32 instances of self injury in children that include jumping from buildings and rushing out into the road. In Japan, a total of 54 deaths have been linked to Tamiflu since the drug was approved. Japan has been one of the most profitable markets for Tamiflu with close to 6 million people using it during the 2004-2005 flu period.

In 2007, an FDA panel report confirmed that the deaths in Japan were connected to neuropsychiatric behavior. Roche Laboratories Inc. has acknowledged the Japanese reports of deaths and self injuries linked to Tamiflu, but insists that there is not enough evidence to prove these deaths were caused by Tamiflu. The FDA, however, recommended that Roche issue a warning cautioning users about the neuropsychiatric behavior and its potentially fatal effects.

Finally in March 2008, the FDA announced that Tamiflu would now come with a strong warning, linking the drug to abnormal behavior that could lead to self injury and death. The updated label stresses the importance of observing patients closely and watching for any signs of delirium, confusion or other unusual behavior, and includes reports of fatal self injuries in patients taking the drug. However, the warning label also claims that these reports of injuries are uncommon, and that suffering from the flu itself can place individuals at risk for neuropsychiatric problems including seizures, confusion and unusual behavior.