18-Dec-12 9:00 AM  CST

Updated Safety Review on Chantix (varenicline)

The Food and Drug Administration (FDA) has released an updated safety review concerning the smoking-cassation drug Chantix (varenicline).  The results of a large scale combination study called a meta-analysis looked at clinical trials which compared patients that took Chantix (varenicline) next to those patients that took a placebo pill with inactive ingredients.  The following adverse cardiovascular events were noted in those that took Chantix instead of the placebo pill.  It is uncertain if the adverse events were due to patient’s circumstances or due to the drug.  Cardiovascular events could possibly include cardiovascular related death, nonfatal heart attack, and nonfatal stroke.  Healthcare professionals and doctors are always advised to outweigh the risks of Chantix versus the benefits of prescribing the prescription drug. 

Pharmacists and pharmacy technicians can advise patients concerning smoking cessation and the use of Chantix.  If patients find themselves experiencing new or old symptoms of cardiovascular disease due to Chantix or not due to Chantix they should report any and all symptoms to their doctor.

Adverse events due to Chantix should be reported to the Food and Drug Administration by filing a report with the event reporting program by going to http://www.fda.gov/Safety/MedWatch/default.htm

1.  Drugs.com Reports.  “Chantix (Varenicline):  Safety Communication – Updated Safety Review On The Risk Of Cardiovascular Adverse Events.”  Drugs.com.  Web.  12 Dec 2012. 

2.  FDA Reports.  “FDA Drug Safety Communication:  Safety Review Update of Chantix (Varenicline) and Risk of Cardiovascular Adverse Events.”  FDA.  Web.  12 Dec 2012.       

3.  ASHP Daily Briefing Repots.  “FDA Analysis Confirms Anti-Smoking Medicine’s Link To Heart Risks.”  ASHP.  Web.  13 Dec 2012.         

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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