Chantix Banned for Pilots
Pfizer’s new anti-smoking drug Chantix was given more unhappy news after a group’s report that it can have serious physical side effects. The Federal Aviation Administration banned Chantix use by pilots and air traffic controllers.
The report, from the Institute for Safe Medication Practices, states that hundreds of serious problems have been reported since Chantix was approved in May 2006, which include dizziness, loss of consciousness, seizures, and abnormal spasms and movements.
The immediate safety concerns regarding the use of varenicline (Chantix) is that pilots operating aircraft, trains, buses and other vehicles, could experience a lapse in alertness or motor control that could lead to massive, serious injuries, researchers said in their report.
FAA spokesperson Les Dorr indicated that the Chantix ban starts immediately and that the FAA was notifying unions representing pilots and air traffic controllers. Dorr said the FAA does not know of any aviation accident caused or contributed to by Chantix.
Pfizer has publicly reaffirmed its stand on Chantix’s safety and said the product label already has safety warnings specifically about driving or operating machinery.
The FAA report cites 173 serious events including accidental injuries–there were 28 road accidents and 77 falls. Also reported were 68 cases of blurred vision, 86 cases of seizures and 372 reports of neurological movement disorders. The researchers have suggested the FDA should study the potential risks.
Congress has given the FDA the authority to order label changes for medications and to conduct safety studies after several medicines, such as Merck’s arthritis drug Vioxx, were pulled from the market because of concern that they had possible safety risks.
In guidelines from the U.S. Public Health Service doctors should prescribe the drug to help smokers quitbut also mention possible association with depression and suicidal behavior. The popular drug is the most effective treatment for stopping cigarette smoking. Nicotine use may be used more by people who already suffer from depression, which complicates efforts to stop smoking.
Chantix sales were $277 million during the first quarter of 2008, up 71 percent from 2007. The 2007, Chantix sales were $883 million.
ref: http://www.faa.gov/news/updates/?newsId=56363
