Researchers recommend new Chantix warnings
October 31st, 2008 by Kurt Niland
Researchers at the Institute for Safe Medicine Practices, a nonprofit organization, and Wake Forest University say that their latest review of Chantix data justifies stepping up warnings about the drug.
More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.
Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.
While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. The Food and Drug Administration is currently reviewing the data to determine if Chantix should carry warnings against driving and operating machinery altogether.
“FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate,” said FDA spokesman Christopher DiFrancesco in an email to Reuters.
Earlier this year, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix. The Federal Motor Carrier Safety Administration also prohibited the use of Chantix.
“It appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle,” FMCSA Administrator John H. Hill said in a public statement.
Chantix sales in the U.S. declined more than a third following warnings about dangerous side effects and a subsequent suspension of Pfizer’s advertising campaign. Sales outside of the U.S. rose by 3 percent.
Chantix plays a key role in Pfizer’s financial pipeline as its other blockbuster drug Lipitor will go generic after July 2010.