FDA Advisory Panel Supports Stronger Warnings for Flu Medications
December 05, 2007
On November 27, 2007, U.S. health advisors recommended stronger warnings on the labels of 2 flu medications, Tamiflu® (Roche) and Relenza® (GlaxoSmithKline), due to reports of abnormal and sometimes fatal psychiatric behaviors.
The U.S. Food and Drug Administration (FDA)’s advisory panel reviewed the cases (mostly in Japan) of patients who have experienced hallucinations and delirium as a result of these 2 medications. Reports in patients that have taken Tamiflu® resulted in erratic behavior, including jumping from buildings, which resulted in deaths. In March, Japan warned against prescribing Tamiflu® to children and adolescents 10 to 19 years of age after reports of strange and erratic behavior increased secondary to taking Tamiflu®.
There has not been a direct link established between adverse events and the influenza agents. About 700 cases of psychiatric adverse events for both drugs, and 25 cases of pediatric deaths in patients taking Tamiflu®, have been reported to the FDA through May 2007. No fatalities were reported for Relenza®. The FDA advisory panel recommended that new case reports and a stronger label warning be added to the prescribing information for Tamiflu® to note patient deaths. For Relenza®, addition of a warning about hallucinations and delirium is recommended.
The flu virus is a major cause of death in the U.S. It is important to note that unusual behavior may be seen in patients with the flu, even those that have not taken antiviral medications. Therefore, the causes of psychiatric adverse effects may be related to the virus itself. While the FDA continues to investigate a direct link between psychiatric effects and the influenza medications, Tamiflu® and Relenza®, patients and providers should be mindful of these events.