Tougher warning ruled for Tamiflu
The European drug regulator has ruled there should be toughened product warnings on oseltamivir (Tamiflu) because of the risk of neuropsychiatric adverse events.
It follows a series of reports of abnormal behaviour in Japan and a small number in the UK.
The agency's Committee for Medicinal Products for Human Use recommended addition of the warning: 'Convulsion, depressed level of consciousness, abnormal behaviour, hallucinations and delirium have been reported during Tamiflu administration, leading in rare cases to accidental injury.
'Patients, especially children and adolescents, should be closely monitored.'
A subgroup of the UK's Medicines and Healthcare Products Regulatory Agency reported several adverse drug reactions at its last meeting. These were 'related to confusion and agitation in elderly patients'.
There have been no reports relating to depression or suicide in the UK. But the European Medicines Agency has received 22 recent reports of abnormal behaviour and four deaths of people in Japan prescribed Tamiflu, and reports of several other incidents in Europe.
A spokesperson said the recommendation was pending endorsement by the European Commission, and that a decision was expected 'very soon'.