One of the State's most commonly prescribed antidepressant drugs has been recalled by the Irish Medicines Board so that the accompanying patient information can be updated to include a new reference to the risk of suicide.
The IMB has asked the manufacturer to recall all stocks of paroxetine - sold as Seroxat - so that packs containing an updated patient information leaflet are available to consumers. A spokeswoman said that the IMB had been assured by the manufacturer, GlaxoSmithKline, that there would be no interruption in supply of the drug.
The new patient information includes the following: "Occasionally, the symptoms of depression may include thoughts of harming yourself or committing suicide. Until the full antidepressant effect of your medicine becomes apparent, it is possible that these symptoms may increase in the first few weeks of treatment. Tell your doctor immediately or go to the nearest hospital if you have any distressing thoughts or experiences during this initial period or at any other time."
It emerged earlier this week on the RTÉ radio programme Liveline that GlaxoSmithKline had changed the patient information leaflet in Britain without changing it here.
However, in a statement, the IMB said that it had agreed new wording with the company in December 2001. This followed a review of the product in June 2001, after which it had been decided to "revise the wording on the licence and patient information leaflets to include a reference to suicidal behaviour and depression".
The statement added that the IMB was now aware that this information was not included in packs here and it had "instructed the company to recall all stock at wholesale level".