In response to a number of recent reports of serious side effects associated with the stop-smoking medication Chantix, Beasley Allen has launched a web site that outlines the problems associated with the drug, manufactured by Pfizer. The web site, beasleyallen.com/matter/chantix/, provides information to help patients identify risks associated with Chantix.
“Chantix is being marketed as a miracle drug that has the potential to help millions of smokers break their addiction to nicotine, but we are beginning to see a darker side,” said Scott Thomas, Director of Internet Services for Beasley Allen. “New research suggests a link between Chantix and suicide, homicidal thoughts, heart trouble, psychosis, diabetes, Stevens-Johnson Syndrome and even liver failure. We have been watching Chantix very closely over the past year and felt the public would be best served by a website dedicated to providing easy access to this new information.”
Since its approval in 2006 as a smoking-cessation aid, Chantix (varenicline) has been prescribed to more than 4 million patients.
As early as November 2007, the FDA issued an Early Communication to the public and health care providers, announcing it was investigating reports of adverse events, including changes in behavior, agitation, depressed mood, suicidal ideation and actual suicidal behavior.
On February 1, 2008, the FDA issued a Public Health Advisory on Chantix requesting the manufacturer add new safety warnings. In May, the Federal Aviation Administration banned its pilots and air traffic controllers from using Chantix as a result of adverse event reports.
The FDA had more accounts of serious side effects tied to Chantix in the fourth quarter of 2007 than from any other drug.