THURSDAY, Dec. 13 (HealthDay News) -- People who take the
prescription quit-smoking drug Chantix may be at higher risk for
cardiovascular problems, and doctors should weigh the risks of the
drug against it benefits, the U.S. Food and Drug Administration
A major review of clinical trials that compared patients who
took Chantix (varenicline) to patients who took a placebo found
that those who took the drug had slightly higher rates of serious
cardiovascular events such as nonfatal heart attack, nonfatal
stroke and cardiovascular-related death, according to an FDA drug
safety communication released Wednesday.
However, the increased risk among people taking Chantix was not
statistically significant, which means that it is unclear whether
their increased risk was due to the drug or due to chance, the
Chantix works by blocking the effects of nicotine on the brain.
The FDA first alerted the public in June 2011 about the possible
increased risk of cardiovascular problems associated with Chantix.
The agency told Pfizer Inc., the maker of Chantix, to conduct the
data review to learn more about possible heart risks associated
with the drug.
The new findings are similar to those in a clinical trial
described in the FDA's June 2011 drug safety communication about
Chantix. The warnings and precaution section of the Chantix label
has been updated to include the results of the recent review, the
For now, doctors should consider the risks and benefits of
Chantix before prescribing it for patients. The agency noted that
smoking is a major risk factor for heart disease, Chantix is
effective in helping people to stop smoking, and quitting smoking
brings immediate and significant health benefits.
Patients taking Chantix should contact their doctor if they
develop new or worsening symptoms of cardiovascular disease, such
as chest pain, shortness of breath, calf pain when walking, or
sudden onset of weakness, numbness or difficulty speaking, the FDA
The agency also said that patients with questions or concerns
about Chantix should talk to their doctor.
The American Cancer Society offers a
guide to quitting smoking.
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