The manufacturers of the anti-malaria drug Lariam have been asked by the Irish Medicines Board to update patient information it provides with the drug to include more detailed information on possible side effects.
The new details that must now be included with the drug include the fact that psychiatric reactions that have been reported in association with Lariam have in some cases "been reported following discontinuation of treatment".
These reactions are sometimes "disabling and prolonged" and include depression, mood changes, anxiety, confusion, hallucinations, panic attacks, restlessness, forgetfulness, psychosis and paranoia, emotional instability, aggression and agitation.
The patient-information leaflet now also includes the following: "There have been rare reports of suicidal ideation, and suicide, however to date, a causal relationship with drug administration has not been established".
The Irish Medicines Board said it had been in discussions with Roche, the manufacturers of the drug, for some months in relation to its licence for the drug and the patient-information leaflet.
"Whilst the patient information contained in the original leaflet was very comprehensive in relation to potential side-effects it was agreed that further strengthening was necessary," it said.
"Following detailed deliberations with Roche, the licence and patient leaflet wording specification has been changed. The final agreed wording was approved by the IMB on April 15th, 2003, and the Irish licence and patient information leaflet for Lariam has been amended accordingly.
"Under the normal time specification of patient-information leaflet amendments, the company has three months from the date to ensure all product packaging contains the new information," it added.
To date, the IMB has received 48 reports of suspected adverse reactions to Lariam since it was licenced in 1989.
"These reports range from hair loss, amnesia through to fatigue, nausea and nervousness and include two reports relating to suicide attempts," it said.
The changes requested by the IMB follow alterations to the patient-information leaflet in the US over the past year.
Lariam was recently cited in the Central Criminal Court as a possible factor in the murder by a father of his 20-month-old son in Clane, Co Kildare, in April 2001. Yusif Ali Abdi (30), a refugee from Somalia, was jailed for life this week after a jury found him guilty of the murder of his son, Nathan Baraka Andrew Ali.
Ali Abdi was prescribed Lariam in December 2000 and took one tablet a week for five weeks. He had also been prescribed anti-depressants. He told his trial he had "flashbacks", "hallucinations" and "voices in his head" in the months before the killing, and that on the night he took his son from his bed and swung his head against a kitchen wall, a voice in his head had commanded him to "take him, take him" and "hit him, hit him".
In evidence, psychiatrists agreed Lariam could not be ruled out as a factor in the killing.
The managing director of Roche Ireland, Mr Mark Rodgers, pointed out yesterday that there were 30,000 cases of malaria among Europeans and North Americans every year after travelling to affected areas. "Up to 7 per cent of these are fatal," he said.
People had to assess the risk-benefit ratio, he explained. "There is a chance of between one in 10,000 and one in 20,000 of having a severe neuro-psychiatric event after taking Lariam."