Tamiflu ( Oseltamivir ) is an antiviral approved in the European Union for the treatment of influenza in children between 1 and 13 years of age and for the prevention and treatment of influenza in adolescents over 13 years and adults.

Two cases of alleged ‘suicide’ associated with treatment of influenza, involving a 17-year-old boy in February 2004 and a 14-year-old boy in February 2005, were reported to the EMEA ( European Medicines Agency ).

In both cases the adolescents exhibited abnormal/disturbed behaviour, which led to their deaths.

No causal relationship has been identified between the use of Tamiflu and psychiatric symptoms, such as hallucination and abnormal behaviour.

The EMEA stresses that the assessment of psychiatric events during Tamiflu treatment is difficult because:

- Other medicines are often taken at the same time as Tamiflu;

- Patients with influenza and a high fever can show psychiatric symptoms. This is particularly relevant for children and elderly patients.

Hypersensitivity to Tamiflu is the only listed contraindication.
The most frequently reported adverse effects during Tamiflu treatment both in adults and children are nausea and vomiting.

In pre-licensing clinical trials, the rate of these adverse effects has been approximately 5% units greater than the corresponding rates in placebo recipients.

Discontinuation of the treatment because of side effects has been very rare.

Serious skin reactions, including Stevens-Johnson syndrome and erythema multiforme have been reported rarely.

Additionally, there are rare reports of hepatobiliary system disorders including hepatitis and elevated liver enzymes in patients with influenza-like illness.

There are no adequate data from the use of Tamiflu in pregnant women. In pre-licensing animal studies, no evidence of foetal toxicity or teratogenicity was observed.
In rodents, Tamiflu has been shown to be secreted into milk. There is no information on secretion into breast milk in humans.

According to the approved product information in EU, Tamiflu should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Furthermore, Tamiflu should be used during lactation only if the potential benefit for the mother justifies the potential risk for the nursing infant.

Source: EMEA, 2005


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