February 25, 2008

Publication: Sunday Independent

Date: Sunday, February 24, 2008 Page: 12


Headline: Drug labels must carry suicide alert

Drug labels must carry suicide alert Regulator issues safety ruling on all anti-depressant medicines sold here.  ALL BRANDS of antidepressant for sale in Ireland will have to carry a warning that the side-effects may include suicide. After a review carried out by the US Food and Drugs Agency, 33 products which are also widely prescribed in Ireland were deemed to carry a significant risk and merit the warning.

The US Food and Drug Administration analysed 295 studies of antidepressants involving 77,000 people who were on the medication, and found that the risk of suicide in young people was almost twice that of adults aged over 25. The requested labelling 'changes apply to the entire category of antidepressants. In a statement, the US Medicines and Healthcare Products Regulatory Agency, said that the wording of warnings to be printed on all products has been agreed with the European Union.

Significantly, the suicide black box warning which is the strongest regulators can impose covers every single brand of antidepressant. Some of the better-known drug brands on sale in Ireland include: Prozac, Zyban, Olanzapine, Marplan, Paxil, Limbitrol, Celexa and Wellbutrin. Last night the Irish Medicines Board confirmed that all antidepressants sold in Ireland will now have to carry a suicide warning. "Following a review of the issue at European level, companies that hold authorisations for antidepressant products in Ireland have been requested to update their product information with regard to suicidal thoughts or behaviour," a Medicines Board statement said. "These warnings apply to all medicines in Ireland for the treatment of depression," explained Eoin Quinn, who is a spokesperson for the medicine's regulatory agency.

Dr Michael Corry, a consultant psychiatrist who has studied Ireland's current suicide epidemic, strongly believes that there is a link between suicides and the over rescribing of anti-depressants. "Twenty per cent of suicides were found to have anti-depressant medication in their bloodstream. "What does that tell you? Unquestionably there is a link to the current suicide epidemic," said Dr Corry.