The Irish Medicines Board (IMB) has said it is "continuing to monitor" the risks of suicide associated with antidepressants following a fresh warning on the drugs by the US Food and Drug Administration.
The IMB said it was aware of the FDA advisory last week putting doctors, patients, families and other caregivers on notice to be particularly vigilant for signs of worsening depression or suicidal thoughts.
The warning followed a review of the results of antidepressant studies since June 2003 on range of serotonin re-uptake inhibitors (SSRIs), including Proxac, Serzone and Wellbutrin.
A spokeswoman for the IMB said the FDA warning was not based on any new clinical trials but was rather a reaffirmation of prior advice.
Nonetheless, she said: "The IMB will continue to monitor this issue, review any new data that becomes available and initiate any regulatory action considered appropriate."
She added: "In Ireland, the product information for this group of antidepressants already includes information for healthcare professionals and patients regarding the need for monitoring and the risk of suicide."
In October 2002, the IMB ordered the recall of one of the State's most commonly prescribed antidepressant drugs, Seroxat, because its patient information leaflet failed to include a warning on the risk of suicide.
The IMB then said it had agreed new wording with the company 10 months previously and had not been aware the information was excluded from packs in Ireland, unlike in the UK.
The new patient information included 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."
Last year, the IMB requested a number of further changes to the patient information leaflet supplied with Seroxat.
Manufacturers GlaxoSmithKline were told both to withdraw a claim on the leaflet saying the drug was not addictive, and to include a warning that the drug should not be given to under-18 year olds with major depressive disorder.
The latter alteration followed studies, undertaken by GlaxoSmithKline, showing what the IMB called "an increased rate of self-harm and potentially suicidal behaviour in children and adolescents treated" with Seroxat.
While Seroxat had not been licensed for use among under-18s in the Republic, the IMB last year estimated that up to 350 under-18s were taking the drug because doctors had the authority to prescribe any product for a patient under their care if they deem it appropriate in a particular case.
