A drug licensed in the Republic to treat patients with influenza has been implicated in the deaths of a number of patients in the United States.
The manufacturers of the drug, Glaxo Wellcome Ltd, wrote to GPs across the State this week informing them that the drug Relenza could trigger breathing problems in certain patients, such as those with asthma.
Their alert followed confirmation that up to 10 patients in the US had suffered side-effects as a result of using the drug, which comes in an inhaler format.
The Irish Medicines Board (IMB) confirmed yesterday that Relenza is authorised for the treatment of influenza in adults and adolescents over 12 years.
In a statement, its chief executive, Dr Frank Hallinan, said: "The Irish Medicines Board recently received foreign reports of bronchospasm/worsening of respiratory function (some of which have been fatal) following inhalation of Relenza in patients with underlying lung disease."
It added that the board had not received any reports of worsening of respiratory function following use of the drug here.
Dr Hallinan said the IMB, in association with the manufacturers, had reviewed this information and issued a number of recommendations:
Patients who experience bronchospasm or decline in respiratory function should stop using Relenza and seek advice immediately.
Patients with asthma or other breathing disorders should be informed of the potential risk of bronchospasm when using Relenza. They should ensure that a fast-acting bronchodilator is available.
Patients on maintenance bronchodilator therapy should use their bronchodilators before taking the drug.
In its statement, Glaxo said extensive clinical trials involving over 6,000 patients had shown Relenza to be effective and well tolerated, helping to reduce the duration and severity of symptoms and complications associated with influenza. It added that up to one million prescriptions of the drug had been issued to patients worldwide to date.
"Following the widespread use of Relenza this season, rare cases of respiratory adverse events have been reported (none in Ireland). In response to this, Glaxo Wellcome has written to all doctors and pharmacists to highlight this information," the statement said.
It added that there had been no deaths in which Relenza had been established as the cause.