Personal Injury Law

Chantix Use Banned For Truckers

By Jane Akre

The chorus of consumer complaints about the drug, Chantix is getting louder and louder.

Yesterday, the Federal Aviation Administration banned use of the smoking cessation drug for pilots and air traffic controllers.

Now the trucking industry wants drivers of big-rigs to stay off the drug.

The Federal Motor Carrier Safety Administration oversees the interstate trucking and bus industry.  Thursday it issued a warning to medical examiners who qualify truckers for commercial driving licenses against issuing licenses to users of Chantix.

The drug has had a controversial history in its two years on the market. Long linked to vivid dreams, it is increasingly found to increase psychotic episodes, dizziness, seizures, heart irregularity and diabetes. 

Yesterday a report from the nonprofit group, The Institute for Safe Medication Practices, found further problems, reporting Chantix was connected to 988 serious events in the last quarter of 2007.

Based on adverse events reported to the FDA, the report cites 28 suicides, 41 cases of homicidal thinking, 224 reports of heart trouble, more than 500 reports of hostility and aggression and nearly 400 cases of possible psychosis.

Of special concern for those operating airplanes or trucks - there were 173 serious injuries, some resulting from traffic accidents where drivers were dizzy, mentally confused or became unconscious.

The nonprofit group concludes, "We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.  Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices.   Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline may not be safe to use in these settings."

Based on the report, the F.A.A banned the drug for use among pilots and air traffic controllers.   

The warning label on Chantix was updated earlier this year to include suicidal tendencies and depression.  In its two years on the market, Pfizer has updated its warning label twice.  

The drug reportedly added $277 million to the drug maker's first-quarter profits but sales are down 32 percent since January. It's estimated about 3.5 million Americans have taken Chantix.   

Pfizer tells the Los Angeles Times to consider the risk versus benefit ratio.

Smoking "is one of the largest problems we face in the world," said Dr. Anjan Chatterjee, a Pfizer medical director. "When you think about it in that perspective, the risk-benefit analysis is still substantially toward benefit. Even medications most people consider innocuous have side effects."  #

Full post as published by InjuryBoard on May 22, 2008 (boomark / email).