• Study Finds Elevated Heart Risk With Stop-smoking Drug
  • The popular smoking cigarettes cessation drug Chantix may dramatically increase the risk of serious heart problems, according to a medical study led by a Johns Hopkins University School of Medicine researcher.

    The findings of the study, released Monday in the Canadian Medical Association Journal, describe a 72 percent greater risk of "serious adverse cardiovascular events," such as heart attacks, for users of Chantix (varenicline).

    Dr. Sonal Singh, assistant professor of general internal medicine at the Johns Hopkins University School of Medicine, led the research effort, which analyzed data from 14 previous placebo-based clinical trials involving 8,216 patients.

    Spokeswomen for cardiologists at Southcoast Health System and Hawthorn Medical said the specialists there were not yet familiar enough with the report to comment.

    However, the New York Times reported Monday that the study differed from past ones, because it excluded those with cardiovascular disease, to give a better picture of which heart problems the drug could cause in otherwise healthy people trying to quit smoking cigarettes.

    According to the Times, Chantix, manufactured by Pfizer, has been prescribed to 13 million people and had $755 million in sales last year.

    In a statement posted on its website, Pfizer expressed concerns about the reliability of the study, including the way the data was analyzed.

    "Pfizer scientists and doctors continuously evaluate the benefits and risks of its medicines, including Chantix," Dr. Gail Cawkwell, vice president of medical affairs, said in a statement. "The currently available safety data on Chantix, including a pooled analysis of clinical data in 7,375 people trying to quit smoking cigarettes, do not support an increased cardiovascular risk associated with Chantix."

    Chantix has been the subject of intense scrutiny of late. In May in a widely reported case, the family of Sean Wain, accused of killing his wife and then himself in Beaver County, Penn., in 2009, filed a lawsuit that said the drug caused their relative's violence.

    Pfizer lists "hostility, agitation, depressed mood (and) suicidal thoughts or actions" as potential side effects for Chantix users.

    In June, the Food and Drug Administration issued an additional safety warning that said Chantix "may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease."

    While authors of the new report acknowledge that Chantix "increases the chances of a successful quit attempt by twofold compared with unassisted smoking cigarettes cessation," they urged medical professionals to follow up with further safety trials regarding the drug.

    "Until such trials are conducted, clinicians should carefully balance the risk of serious cardiovascular events ... against the known benefits of the drug on smoking cigarettes cessation," they wrote.

    The findings resonate in New Bedford, where a large segment of the population smokes regularly. According to the Massachusetts Tobacco Cessation & Prevention Program FY2009 Annual Report, 28.7 percent of the city's residents smoked cigarettes in 2008. Comparatively, 16.1 percent of all Massachusetts residents used cigarettes online at that time.

    Local residents who smoke cigarettes said they were not overly surprised by the report.

    "New drugs come out but, a year later, the lawyers have a class-action suit," John Perriera of Mattapoisett said. Perriera said he finds it difficult to figure out which smoking cigarettes cessation drugs are actually safe.

    New Bedford's Zack Kampersall agreed, saying he had already heard about studies showing adverse side effects from Chantix before the latest findings. He said he knew somebody who complained of depression after using the drug. Kampersall said he probably will never use Chantix for fear of such side effects.