November 18, 2005
Is Tamiflu safe for kids? With a potential bird flu pandemic in the making, the Food and Drug Administration (FDA) is looking for answers, in the wake of reports that 12 children died in Japan after being trested with Tamiflu, a powerful antiviral drug.
Tamiflu is currently approved for treatment of uncomplicated influenza A and B in patients 1 year of age or older and is the leading candidate for widespread use if a bird flu pandemic breaks out. While there are no vaccines against bird flu, health officials believe Tamiflu might be effective in helping victims recover from it.
The stepped-up safety review is mandated by the Best Pharmaceuticals For Children Act because of reports of adverse events in children 16 years of age or younger, including unusual neurologic or psychiatric events such as delirium, hallucinations, confusion, abnormal behavior, convulsions, and encephalitis.
These events were reported almost entirely in children from Japan who received Tamiflu according to Japanese treatment.
The review identified a total of 12 deaths in pediatric patients since Tamiflu's approval. All of the pediatric deaths were reported in Japanese children. In many of these cases, FDA said a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail in the reports.
Initially, it was not clear why the neuropsychiatric adverse events and deaths were reported almost entirely in Japanese children. The FDA receives adverse event reports from all over the world and usually adverse events are roughly the same from different reporting countries," the agency said. "The reports of death and neuropsychiatric events associated with Tamiflu, almost entirely from Japan, was unusual enough to prompt further evaluation."
The FDA said it has requested additional information from both Hoffman-La Roche, the pharmaceutical company which produces Tamiflu, and the Japanese Ministry of Health, Labor, and Welfare. FDA said it is evaluating several possible explanations for the adverse events.
The Pediatric Advisory Committee discussion is not directly addressing any issues related to pandemic flu preparations, the FDA said in a statement. Indirectly, a better understanding of Tamiflu safety in children will be useful should a pandemic occur and there is widespread use of Tamiflu.
