Pharmacists told to warn patients of anti-depressant suicide information
The instruction was issued by the Irish Medicines Board (IMB) following the discovery that its manufacturers, GlaxoSmithKline, had failed to include the reference despite being told to do so last December by the IMB.
The IMB has ordered the company to recall the product from wholesalers and issue a clarification letter and the revised patient information leaflet to pharmacists and doctors.
The recall came in the wake of concerns raised by callers to RTE’s Liveline show this week, some of whom spoke of attempts at self-mutilation while on the drug. A number of callers also claimed relatives had committed suicide while taking Seroxat.
The IMB and GlaxoSmithKline have both stressed that the drug recall is not linked in any way to the safety of the product, only to the difference in patient information between the UK packs and Irish packs of the drug.
Failure by GlaxoSmithKline to include the reference to suicide and self-harm in its Irish packs of Seroxat was first raised on Liveline in July 2001, by a Dublin doctor, Dr David Healy. Speaking yesterday on Liveline, he disputed the claim that the drug was not linked to suicidal behaviour.
“There is good causal evidence to say that the pill can make people suicidal,” he said, adding that people who took part in clinical trials of the drug and were not suicidal to begin with, had, on occasion, ended up suicidal.
The reference on the drug pack says that thoughts of self-harm or suicide are linked to the illness, not the treatment.
However, Dr Healy said failure by the company to immediately act on the IMB’s recommendations could leave GlaxoSmithKline legally exposed, if patients on the drug had tried to harm themselves in the past six months.
Both the IMB and the company said the decision to bring the information in the Irish packs in line with the UK was the result of an expert review in the summer of 2001 and was not linked to any radio programme.
A spokeswoman for GlaxoSmithKline said the suicide reference had not been defined as critically urgent and had been brought to the UK manufacturing site in May, too late for March/April supplies to the Irish market. Glaxo, whose stock fell by over 2% yesterday has 16% of the Irish anti-depressant market share. Up to 200,000 Irish people suffer from depression.
