Those who have studied the potential link between varenicline (Chantix) and adverse cardiovascular effects have come down pretty hard on a drug that was fast-tracked to market by the US Food and Drug Administration (FDA) and showed so much promise early on.
A lead author of a study on the potential link involving Chantix heart issues calls the risk "substantial.
"The FDA should have already put [Chantix cardiovascular risk] on their warning label," said Dr. Sonal Singh, assistant professor of medicine at the respected Johns Hopkins University. "The risk is substantial, the risk is present in smokers without heart disease."
In other words, while smoking over the long term can damage the lungs and heart, attempting to quit smoking using Chantix by a patient with no history of heart disease could be facing dire consequences.
The senior author of the study, Dr. Curt D. Furberg of Wake Forest, called for the removal of Chantix from the market altogether.
"We have known for many years that Chantix is one of the most harmful prescription drugs on the US market, based on the number of serious adverse effects reported to the FDA,'' Furberg said in a statement. "It causes loss of consciousness, visual disturbances, suicides, violence, depression, and worsening of diabetes. To this list we now can add serious cardiovascular events."
READ MORE CHANTIX HEART ATTACK LEGAL NEWS
For a balanced view, the Journal ran a separate commentary by a doctor from the Mayo Clinic in Rochester, Minnesota. While describing the meta-analysis as "timely and important," Dr. J. Taylor Hays noted that the study lacked size and standardization overall—concluding that the benefits of quitting tobacco continued to outweigh any risks associated with Chantix.
Pfizer agreed, noting in a statement that in its view the study included too few heart or cardiovascular events to draw conclusions about the risks. In standing behind its product, Pfizer noted the "immediate and substantial" health benefits to smokers who quit.
Chantix lawsuits would beg to differ.