The FDA has recommended that the label of Roche’s popular flu drug, Tamiflu, be updated to carry warnings about possible “neuropsychiatric adverse events,” particularly in pediatric patients. The recommendation follows a 10-month review of 103 cases of unsafe behavior, 67 percent of which occurred in pediatric patients. Most of the events, 95 percent, occurred in Japan, which is Tamiflu’s largest consumer. The reports include two deaths, a 14-year old boy who fell after climbing on his condominium balcony railing, and an adult who left a suicide note.
Japan’s labeling already carries warnings about behavioral events, and the FDA said “it would be prudent to update the U.S. labeling to be similar in scope.”