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A study published Monday in a Canadian journal concluded that smokers who take Chantix, one of the most popular smoking cessation drugs, could increase their risk of heart problems. Chantix (varenicline) could raise the risk of heart attacks and irregular heartbeats, said one of the study authors, Dr. Sonal Singh, an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine. The heart problems are the latest in a growing list of concerns raised by patient reports, lawsuits and studies since the drug's approval in 2006. The drug could cause changes in behavior, hostility, agitation, depressed...

Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through “improper channels.” Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices. “We’ve had a major breakdown in safety surveillance,” said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems — including reports of...

James Elliott thought his recurring nightmares of exploding bombs, dogs eating corpses, a child's head blown off its body and other war horrors from his Iraq tour had ended in 2004 when he returned to his home in Silver Spring. The Army veteran sniper was earning high grades in college and got engaged to be married. His post-traumatic stress disorder (PTSD) had disappeared. He even signed up for a Veterans Affairs experiment to kick his habit of nearly three packs of cigarettes a day using the drug Chantix, and was succeeding. But after two weeks on the drug, his night...

The Federal Motor Carrier Safety Administration issued a warning Thursday on the anti-smoking drug Chantix, advising medical examiners "to not qualify anyone currently using this medication for commercial motor vehicle licenses." The FMCSA oversees the interstate trucking and bus industry. Chantix, made by Pfizer, Inc., was attacked in a study by a non-profit group on Wednesday for possible links to seizures, dizziness, heart irregularity, diabetes and more than 100 accidents. The Department of Transportation alerted its agencies about the study, asking the office directors be aware of the report's warnings and recommendations. The Federal Aviation Administration banned the drug for...

The Federal Aviation Administration said Wednesday it would no longer permit pilots or air traffic controllers to use the smoking cessation drug Chantix, citing potential side effects that could pose a threat to the safe operation of aircraft. The Food and Drug Administration issued a public health advisory in February, saying that some Chantix users had developed a variety of serious psychiatric symptoms, and that some had committed suicide. An F.A.A. spokeswoman, Laura Brown, said the agency had approved the use of Chantix for airline pilots and flight controllers last year, but was notifying 150 pilots and 30 air traffic...

Melinda and Kenny Peterson wanted to kick their two-pack-a-day smoking habit. In early January, the Green Bay couple started taking three-month prescriptions of Chantix, a new anti-smoking pill. About six weeks later, they weren't smoking at all. But what the Petersons didn't know was that as they were weaning themselves off cigarettes, the U.S. Food and Drug Administration issued an alert: Some patients taking the powerful drug had experienced serious neuropsychiatric symptoms. And Pfizer, the maker of Chantix, had recently added a warning about these symptoms in a more prominent position in the drug's information packet, at the FDA's urging....

FDA: Connection between Chantix, psychiatric problems ‘increasingly likely’The Associated Press updated 1:33 p.m. PT, Fri., Feb. 1, 2008WASHINGTON - Government regulators said Friday the connection between Pfizer's anti-smoking drug Chantix and serious psychiatric problems is "increasingly likely."The Food and Drug Administration began in November investigating reports of depression, agitation and suicidal behavior in patients taking the popular twice-daily pill.The agency's announcement comes two weeks after Pfizer added stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out.In a...