Chantix (Varenicline): Safety Communication - Updated Safety Review On The Risk of Cardiovascular Adverse Events
AUDIENCE: Family Practice, Cardiology, Patient
ISSUE: FDA is informing the public about the
results of a large, combined analysis (called a meta-analysis) of
clinical trials that compared patients who received the smoking
cessation drug Chantix (varenicline) to patients who received a
placebo (an inactive treatment). 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.
BACKGROUND: Chantix is a prescription
medicine used to help adults quit smoking that works by blocking
the effects of nicotine (from smoking) on the brain. FDA first
notified the public about a possible increased risk of
cardiovascular adverse events with Chantix in its June 2011 Drug
Safety Communication (DSC). FDA required the manufacturer of
Chantix to conduct the meta-analysis to further evaluate the
cardiovascular safety of the drug, and believes it is important to
let health care professionals and patients know about the results
of this study. The meta-analysis findings of cardiovascular risk
are similar to the findings in the smoking cessation clinical trial
of patients with stable cardiovascular disease that was described
in FDA’s June 16, 2011 DSC. The Warnings and Precautions
section of the Chantix label has been updated to include the
results of the meta-analysis.
RECOMMENDATION: Health care professionals are
advised to weigh the risks of Chantix against the benefits of its
use. It is important to note that smoking is a major risk factor
for cardiovascular disease, and Chantix is effective in helping
patients to quit smoking and abstain from it for as long as one
year. The health benefits of quitting smoking are immediate and
substantial.
Patients taking Chantix should contact their health care
professional if they experience 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. Patients should also contact their health care
professional if they have any questions or concerns about
Chantix.
Healthcare professionals and patients are encouraged to report
adverse events or side effects related to the use of these products
to the FDA's MedWatch Safety Information and Adverse Event
Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatcxh alert, including links to the FDA Drug
Safety Communication, at:
Posted: December 2012
