Even tobacco executives acknowledge these days that smoking is an environmental risk for cancer. According to the American Lung Association, more than 400,000 American lives are lost each year due to smoking or from secondhand smoke shared with babies and spouses.
Chantix sounded like a lifesaver when it was approved by the Food and Drug Administration in May 2006.
Also known as Varenicline Tartrate, Chantix is made by Pfizer and given to end smoking addiction. The FDA reportedly reduced its usual review time from 10 to six months.
Here’s how it works. Instead of using nicotine, which many smoking cessation therapies include, Chantix reduces cravings and decreases the pleasurable effects of smoking. But side effects reported include nausea, headaches, abnormal sleep, and Chantix dreams, vivid wild dreams.
It’s estimated about 5 million prescription have been written.
In November 2007, the FDA began investigating reports of suicidal behavior among users. 37 reports had come in of suicides and hundreds with suicidal behavior. Pfizer was forced to add a stronger warning on the drug’s label.
Pfizer has suggested that Chantix-induced psychotic episodes are actually due to nicotine withdrawal, but the FDA notes that even people who keep smoking and are taking Chantix have the same episodes.
After ABC News published the story of Carter Albrecht, who, after taking his first 1 milligram Chantix tablet, assaulted his girlfriend, and was shot and killed by a neighbor who thought he was a burglar. ABC received over 200 comments from people describing similar erratic behavior.
By November 2007, the FDA issued a release about Chantix confirming there were an increasing number of reports about radical changes in behavior and suicidal thoughts among users of Chantix. As a result the FDA recommended that healthcare workers monitor Chantix users for behavior and mood changes. Pfizer continues to say that Chantix is a real breakthrough medicine even though by February, 2008, the FDA was saying that after a continuous review of adverse event reports there was likely an association between Chantix and serious neuropsychiatric symptoms.
Considering the evidence, the Federal Aviation Administration in May 2008 ordered pilots and air traffic controllers to cease using Chantix immediately. The government body that oversees the trucking industry, the Federal Motor Carrier Safety Administration, in May 2008 issued a warning to medical examiners who qualify truckers for commercial driving licenses against issuing licenses to users of Chantix.
One year ago, the Los Angeles Times reported that in the first quarter of 2008, Chantix accounted for more serious injuries than the ten bestselling prescription drugs – combined.
Remember that statistics reported to the adverse events reports (AER) database, part of the FDA, likely represent a small percentage of adverse events that actually occur. The AER reporting is largely voluntary and not terribly consistent or reliable.
Even considering that, the FDA reports there have been 98 suicides and 188 suicide attempts report among people taking Chantix since it was approved in the U.S. in 2006.
Pfizer continues to insist that the risk benefit analysis for Chantix still leans toward benefit. If you or a loved one has been injured by Chantix, you may want to speak to a skilled Jacksonville Chantix attorney experienced in pharmaceutical litigation until this dangerous drug is taken off the market.