Oseltamivir: cutaneous and neurological adverse effects in children.
Prescrire Int. 2006 Oct;15(85):182-3. PMID: 17128526
(1) Oseltamivir is an antiviral drug used for influenza. It has only been tested in children to a limited extent. (2) A few deaths have been reported in children receiving oseltamivir, in some cases due to neurological causes. All of these deaths occurred in Japan. The European Medicines Agency has described 2 deaths, both attributed to suicide, in adolescents aged 14 and 17 who were taking oseltamivir. Both patients had developed behavioural disorders before their death. (3) According to the US Food and Drug Administration, neuropsychiatric disorders were reported in 32 children (mainly in Japan), and include delirium, behavioural disorders, hallucinations, convulsions and confusion. (4) Disturbing neurological toxicity has been observed in young rats exposed to oseltamivir, leading the American and European agencies to warn against the use of oseltamivir in infants less than one year old. (5) Severe cutaneous adverse effects, including cases of Lyell syndrome, were reported in children taking oseltamivir. (6) In practice, oseltamivir is only modestly effective in the prevention of influenza and treatment of suspected influenza. There is no evidence of an effect on complications of the flu in adults or children at higher risk. The possibility of serious adverse effects should be weighed against the limited benefit of oseltamivir.