New warnings urged for flu drugs’ labels
Washington, D.C ? Food and Drug Administration experts are recommending new label warnings about possible dangerous psychiatric side effects of influenza drugs Tamiflu and Relenza, according to FDA documents.
The documents, posted Friday on the agency’s Web site, were prepared for a meeting Tuesday of the FDA’s Pediatric Advisory Committee.
Studies revealed 596 cases in which patients who took Tamiflu experienced “neuropsychiatric events” such as delirium, delusions or hallucinations. The episodes sometimes led to impulsive behavior and self-injury. Tamiflu is made by Roche Holdings.
The problems tended to occur within 24 hours of first taking the drug, and the majority were in patients younger than 21, mostly in Japan, according to the documents. In five cases involving pediatric patients, the reported delirium resulted in death, and there were three reports of suicide in adults.