Roche adds neuropsychiatric warnings to Tamiflu's US label

The US Food and Drug Administration has requested that the US label for Roche's Tamiflu (oseltamivir) be revised to include reports of neuropsychiatric events such as self-injury and delirium in patients with influenza. In 2005, the agency received 103 psychological side effect reports from influenza patients on the Swiss drug major's mainstay antiviral, including five deaths. Roche noted that these events are extremely rare in relation to the number of patients treated during the influenza season. Pharmaceutical sector analysts at Lehman Brothers noted that the label change is largely irrelevant as the vast majority of Tamiflu is purchased for governement stockpiling in case of a possible pandemic of avian influenza. The drug is a key performance driver for Roche. In the first half of 2006, Tamiflu sales rose 62% on the like, year-ago period.