Japan Warns on Tamiflu for Teens

What are the important safety issues and adverse events?

When Tamiflu was studied in clinical trials as treatment for children with influenza, children taking Tamiflu experienced similar side effects as children not taking Tamiflu. Serious side effects were not identified. The most common side effects observed in both the treatment and prophylaxis trials were nausea and vomiting. In these trials, a small number of children stopped taking their Tamiflu because of nausea and vomiting or other adverse reactions.

In the safety review mandated by the BPCA, a number of adverse event reports were identified associated with the use of Tamiflu in children 16 years of age or younger. These adverse event reports were primarily related to 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 guidelines (very similar but not identical to U.S. treatment guidelines). 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, 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.

The review also identified severe skin reactions (like allergic reactions) in some pediatric patients. These events were not all reported in Japanese children and have also been reported in adults. Severe skin reactions in all age groups are currently being reviewed in more detail.

Source: http://www.fda.gov/cder/drug/infopage/tamiflu/QA20051117.htm