Reuters reports that the Food & Drug Administration is recommending new warnings about psychiatric problems sufferedby some patients taking Tamiflu and Relenza influenza medications. Excerpts from the story:
In documents…posted on the FDA’s Web site, agency staff recommended that Tamiflu’s label be strengthened to note, “in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients.”
The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note “reports of hallucinations, delirium and abnormal behavior” observed in some patients taking the drug.
FDA staff said the evidence is “conflicting” as to whether the events are medication-related, a manifestation of disease or a combination of the two.
Tamiflu, known generically as oseltamivir, is a pill, while Relenza, generically zanamivir, is inhaled.
A Roche spokesman said no causal relationship between Tamiflu and these psychiatric events has been proven.
“Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies. Roche takes all adverse events reports very seriously,” spokesman Terence Hurley said in a statement.
About 48 million people have taken Tamiflu worldwide, including 21 million kids, since approval in 1999, he said.
A Glaxo spokeswoman said a review of premarketing and post-approval trial data showed no signal of these types of adverse events on patients taking Relenza.
FDA staff reviewed nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.