U.S. FDA, Roche warn doctors on Tamiflu dangers

U.S. regulators and Roche Holding AG have warned doctors of psychiatric events, some of which resulted in death, in patients taking flu drug Tamiflu, regulators said on Tuesday.

Drugmaker Roche wrote a letter, dated February 2008, to health professionals advising them of a recent update to the Tamiflu label, according to a notice posted on the Food and Drug Administration’s Web site.

The revised label includes a new description of reports of delirium and other abnormal behavior, with some cases resulting in fatal outcomes, the letter said. The previous language did not mention any deaths.

The new label says the cases “appear to be uncommon” and “the contribution of Tamiflu to these events has not been established.”

The company said the revisions reflect recommendations made in November 2007 by an FDA advisory panel that reviewed the cases, which have been seen mostly in Japan.

“The changes to the label reflect observations from a growing body of data, which shows no evidence of a causal relationship between Tamiflu and the reported adverse events,” Roche said in a statement.

The new label also notes influenza itself can be associated with various psychiatric problems.