April 2, 2008 -- The flu drug Relenza has new warnings about reported neurologic and psychiatric problems that could lead to self-injury and, in some cases, death.
Those problems -- which include delirium and abnormal behavior -- "appear to be uncommon but may result in accidental injury to the patient," says Relenza's updated label.
It's not clear if Relenza caused any of those problems, which were mainly reported by pediatric flu patients in Japan and tended to start and end quickly.
GlaxoSmithKline, which makes Relenza, revised the drug's label based on recommendations from the FDA's pediatric advisory committee, which has acknowledged that flu can be associated with neuropsychiatric complications, GlaxoSmithKline spokesman Jeff McLaughlin tells WebMD in an email.
"These events may occur after beginning Relenza or may occur when flu is not treated," the drug's label states.
Relenza and Tamiflu belong to the same class of drugs. Relenza is inhaled; Tamiflu is a pill.
GlaxoSmithKline's letter to health care professionals, dated March 11, 2008, is posted on the FDA's web site.