Tamiflu (oseltamivir) safety information for pediatric use

Tamiflu (oseltamivir phosphate) is an antiviral medicine approved for treatment of influenza viruses A and B in patients 1 year of age or older. Tamiflu is also approved for prevention of influenza in people 13 years or older. Tamiflu is in anti-influenza group of medicines called neuraminidase inhibitors. These medicines act by blocking the viral enzyme neuraminidase which help the influenza virus invade cells in the respiratory tract.

Tamiflu precautions for pediatric patients

When used as directed (twice daily for 5 days) Tamiflu can reduce the duration of influenza symptoms in otherwise healthy children by 1 to 1,5 days. Tamiflu also appears to reduce the severity of common flu symptoms. Consequently, it may allow children to normal activities sooner. Tamiflu was also shown to be similarly effective in children who had a history of asthma. Tamiflu did not worsen the asthma symptoms.

Tamiflu has not been studied in children with very severe or complicated influenza who require hospitalization. Therefore it is not known whether Tamiflu will provide the same benefit to children with severe illness.

Tamiflu important safety issues and adverse events for children

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

In a certain safety review, a number of reports for adverse event were identified associated with the use of Tamiflu in children 16 years or younger. These reports were primarily related to unusual psychiatric or neurologic events such as confusion, abnormal behavior, delirium, convulsions, encephalitis and hallucinations. Safety review identified a total of 12 deaths in pediatric patients taking Tamiflu. In many of these cases, a connection to Tamiflu was difficult to assess because of lack of adequate details in reports, presence of other medical conditions or use of other medicines.

This safety review also identified severe skin reactions, like allergic reactions in some pediatric patients. These events have also been reported in adults and were not all reported in children. Severe skin reactions in all age groups are currently being reviewed.