Effect of Tamiflu On Kids Investigated by the FDA

Med Headlines - This week, a Food and Drug Administration panel was scheduled to review reports of abnormal behavior and other brain effects in more than 1,800 children who had taken the flu medicine Tamiflu since its approval in 1999, including 55 in this country. Twenty two of the U.S. reports were considered “serious” with symptoms such as convulsions, delirium or delusions said Terry Hurley, spokesperson for drug maker Roche Laboratories. The anti-viral medication, stockpiled by the millions in countries around the world for use in a flu pandemic, is licensed to treat or prevent flu in patients older than 1 year.

None of the US cases resulted in death. But in Japan, Hurley says, five deaths have been reported in children under 16 as a result of neurological or psychiatric problems. Hurley said that there is no evidence that Tamiflu caused the episodes and notes that similar symptoms have been reported in patients who did not take Tamiflu. He says clinical studies have found no increased risk for psychiatric or neurological disturbances and the company’s evaluation of scientific data found “no potential mechanisms for Tamiflu to cause (central nervous system) effects.” He says the company is doing further studies.

The possible association between Tamiflu and neuropsychiatric effects was first reported in Japan, and in March, the Japanese government issued a safety warning restricting the drug’s use in adolescents. Japan has been a major market for Tamiflu, accounting for 75% of the 48 million prescriptions written. The drug’s Japanese distributor Chugai Pharmaceutical Company announced this month that it would cut by half the supply it had been planning to sell this winter, from 12 million to 6 million courses of treatment.