Tuesday Jul 5, 2011
Researchers have issued a new caution over the use of Champix
quit-smoking tablets after finding they are linked to a 72 per cent increased risk of heart attacks and related conditions.
The Ministry of Health said last week it would recheck the safety
of Champix. This followed the instigation of reviews by medicines regulators in Canada and the United States.
Health Canada said there might be a "slightly increased risk
of heart-related side-effects" in Champix patients with cardiovascular disease.
Smoking increases a person's risk of developing cardiovascular
disease.
The Intensive Medicines Monitoring Programme at Otago University
said it had received reports of changed heart rhythms and sudden death in users of Champix, whose active ingredient is varenicline.
It had also received reports of heart attacks in 12 patients who appeared to have had no history of heart disease.
When Pharmac funded Champix last year, it estimated up to 8000
smokers a year would use it.
The new research, published today in the Canadian Medical
Association Journal, was based on 14 trials involving 8200 patients. Most trials excluded people with a history of heart
disease.
The researchers found a 72 per cent greater risk of "serious
adverse cardiovascular events" - including heart attacks, strokes and changed heart rhythm - among tobacco users on Champix
than among tobacco users on a placebo. Other research has linked Champix to depression, suicidal thoughts and other mental
disorders.
Dr Sonal Singh and colleagues say in their paper that safety
signals in the US about Champix and cardiovascular events in 2006 were not followed up by suitably powerful safety trials.
Until that happened, they said, clinicians should carefully
balance the risk of serious cardiovascular and neuropsychiatric problems against the known benefits of the drug in helping
people to quit smoking.
NZ National Heart Foundation medical director Dr Norman Sharpe
said yesterday that he had seen the journal's latest Champix data, which added to a large body of information indicating concern
about the drug.
"I would say it's a significant concern and something that needs
to be followed closely."
However, a commentary in the journal by Dr J. Taylor Hays, of
the Mayo Clinic in the US, said that although Champix users in the analysis were at a 72 per cent increased risk of serious
cardiovascular problems, their absolute risk was small: just 1.06 per cent of the 4908 Champix users suffered these adverse
events.
"The small absolute risk of cardiovascular events associated
with taking varenicline is outweighed by the enormous benefit of reducing cardiovascular morbidity [sickness] and mortality
that can be achieved with successful abstinence from smoking."
By
Martin Johnston