Roche considers changing Tamiflu labels after FDA panel's call to do so

Swiss drugmaker Roche Holding AG said patients need better information about possible psychiatric risks resulting from the flu, and will consider how to change the labels on its Tamiflu medicine accordingly, a spokeswoman said Wednesday.

Martina Rupp said all patients with full-blown flu should be alerted to the risk of psychiatric problems, not just people taking the Roche product. She said Roche's own analysis of patient data had shown no link between Tamiflu and reported cases of delirium and hallucinations.

"It's important really that the label reflects that influenza itself can trigger such events," she said.

An expert panel for the U.S. Food and Drug Administration recommended Tuesday that Roche adds cautionary language to the label for Tamiflu, which has been used by 48 million patients since its launch in 1999.

The drug's label already mentions reports of delirium and self-injury, primarily among children in Japan, but some of the FDA's experts suggested the language should mention that several patients have died as a result of these abnormal behaviors.

Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75 percent of them coming from Japan. Five children there have died after "falling from windows or balconies or running into traffic," according to the FDA.

Roche presented its own analysis of more than 150,000 patients to the FDA showing no connection between Tamiflu and increased risk of psychiatric problems.

"Over the last year we've been looking at a variety of data and undertaken additional studies that so far have shown no causality between Tamiflu and these events," Roche product director David Reddy said in an interview Tuesday. "In fact, the data increasingly points to the role of influenza in these events."

Rupp said influenza causes fevers that reach 40 degrees Celsius (104 Fahrenheit) or higher, and people "need to know that this is associated with delirium and hallucination."

Tamiflu sales totaled US$1.1 billion (euro800 million) in the first half of 2007. Sales have benefited in recent years from governments stockpiling the drug in case the bird flu virus that has ravaged poultry stocks in Asia mutates into a form that can be easily transmitted among humans, sparking a flu pandemic.