Roche reports Tamiflu safety

Pharmaceutical firm Roche has reported that it has not been established that cases of psychological disorders and death in patients treated with its anti-influenza drug Tamiflu (oseltamivir phosphate) were caused by the treatment.

The company notes that since its approval in 1999, 42 million people worldwide have been treated with the drug. Based on information received from the Food and Drug Administration, the company calculates that approximately one in 100,000 patients suffered psychological disorders and one in two million have died.

“Phase III pivotal trials conducted by Roche found similar reports of neurologic and psychiactric events in pediatric influenza patients being treated with Tamiflu and those receiving no treatment,” the company said.

It added that a US claims database of flu patients both treated with Tamiflu and those untreated also recently confirmed no difference in the rate of neuropsychiatric events.

Roche added that it would continue in its standard and established investigative and notification methods for Tamiflu, including the reporting of any adverse effects to the authorities.

The company announced last month that it had expanded the production of Tamiflu to guarantee supply for the 2006-07 influenza season, in addition to stockpiling for a potential pandemic.