Champix risk uncertainty
July 22, 2011
NEW research has found a link
between smoking cessation
medicine varenicline (Champix) and
an increase in the risk of serious
cardiovascular events.
Published in the Canadian
Medical Association Journal, the
study found a greater number of
cardiovascular events (such as an
irregular heart beat, heart attack or
stroke) with varenicline than with a
placebo.
The study looked at data from 14
clinical trials, and found overall
Champix increased the risk of
cardiovascular events by 72%.
Of the 4,908 patients on Champix
across the trials, 52 were found to
have suffered serious
cardiovascular events, compared to
27 who suffered CV events on
various placebos.
Responding to the latest research,
the NPS said: “there is still some
uncertainty about what this means
for people taking the medicine”.
“Weaknesses of the study make it
hard to determine whether
varenicline caused the
cardiovascular events and also the
true size of any increased risk,” said
NPS Clinical Adviser Dr Danielle
Stowasser.
“It’s important to note that the
reported increased risk of
experiencing a cardiovascular event
for people taking varenicline needs
to be weighed up against the
cardiovascular benefits of quitting
smoking,” she added.
The NPS is advising patients and
healthcare workers who are
concerned about Champix that
there are other effective methods
of quitting such as other drugs and
non-drug options, including
counselling.
Patients are also being advised to
report any new or worsening side
symptoms to their health
professional immediately,
particularly if they experience chest
pain, shortness of breath or trouble
breathing or pain in the legs whilst
walking.
“Varenicline is a relatively new
medicine and its full range of
adverse effects is becoming clearer
with time,” said Dr Stowasser.
Past controversies over the drug
have included claims that it
increases suicidal thoughts and
erratic behaviour in some patients,
a warning that was backed up by
US, EU and Australian authorities
with requirements for Pfizer to list
stronger prescribing and consumer
information warnings.
Side effects can be reported to
the TGA at www.tga.gov.au/hp/
problem-report-howto.htm.
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