NPS urges Champix caution
January 17, 2013
HEALTH professionals need to
weigh the potential small
cardiovascular risks associated with
the quit-smoking medicine
Champix (varenicline) against the
immediate and substantial benefits
of quitting smoking, according to
NPS MedicineWise.
The comments come on the back
of a large, meta-analysis of clinical
trials that compared patients who
received the smoking cessation
drug Chantix (varenicline) to
patients who received a placebo,
conducted by Pfizer by the order of
US Food and Drug Authority.
The FDA first notified the public
about a possible increased risk of
cardiovascular adverse events with
Chantix in its June 2011 Drug Safety
Communication (DSC).
Pfizer’s recent meta analysis
found that a higher occurrence of
major adverse cardiovascular
events (a combined outcome of
cardiovascular-related death,
nonfatal heart attack, and nonfatal
stroke) was observed in patients
using Chantix compared to placebo.
“These events were uncommon
in both the Chantix and placebo
groups, and the increased risk was
not statistically significant, which
means it is uncertain whether the
excess risk for the Chantix group
was due to the drug or due to
chance,” the FDA said in a
statement.
“However, the data analysed
many different ways and
consistently showed a higher
occurrence of events in patients
using Chantix, which makes it seem
more likely that it is related to the
drug and not purely a chance
finding,” the FDA added.
As such, NPS has urged health
professionals advise patients to
seek medical attention if they
experience new or worsening
symptoms of cardiovascular disease
while taking varenicline.
“For people with no history of
cardiovascular disease who are
starting varenicline for smoking
cessation, health professionals
should advise that the medicine
may cause a small increase in their
absolute risk of a cardiovascular
event,” said NPS MedicineWise
clinical adviser Dr Philippa Binns.
“But this small risk needs to be
weighed up against the
cardiovascular benefits if the
patient is successful in quitting
smoking as a result of taking the
medicine,” Binns added.
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