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Smoking Cessation Drug, Chantix, May Cause Serious Heart Side Effects

May 22, 2008 | Parker Waichman LLP

Tuesday, the Institute for Safe Medication Practices, a drug watchdog group, highlighted some serious physical side effects, which may be linked to Chantix, Pfizer's popular smoking-cessation drug.  Chantix has been in the news lately over links to adverse psychiatric issues, drawing more attention to the already beleaguered Food and Drug Administration (FDA) and its questionable drug-safety monitoring practices.

The Institute examined serious adverse side effect reports provided to FDA, including reports of nearly 1,000—988, to be exact—serious injuries linked to Chantix in the U.S. during last year's fourth quarter, a figure higher than any other medication during that same time frame.  The report specifically cites 173 serious events described as accidental injuries, including 28 road accidents and 77 falls as well as 68 cases of blurred vision, 86 cases involving seizures, and 372 reports of movement disorders.  The researchers recommended the FDA initiate an epidemiological study to assess potential risks.  Chantix was approved in May 2006.

“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," the researchers said in the report.  Chantix has linked to issues connected to psychiatric reactions that include including suicide; however, this new information discusses links to serious adverse physical reactions such as cardiac episodes, seizures, diabetes, dizziness, loss of consciousness, and abnormal spasms and movements.

On Wednesday, the Federal Aviation Administration (FAA) banned Chantix use by pilots and air traffic controllers when the Institute called the FAA’s attention to its report.  FAA spokesman Les Dorr said the Chantix ban is effective immediately and that it was notifying unions representing pilots and controllers.  He said the FAA is unaware of any aviation accident caused or contributed to by Chantix.

An FDA spokeswoman acknowledged that the Institute’s study presents safety signals; however, due to FDA staffing shortages, the agency is focusing—for now—on reviewing Chantix's potential psychiatric effects.  Pfizer said the report's findings are consistent with the drug's label, which lists many of the events cited in the Institute's report as "infrequent" or "rare.”

The FDA has been hotly criticized in recent months for not having strong post-approval tracking of prescription drugs and has been at the core of a number of drug safety issues.  Last year, Congress gave the FDA the authority to order drug label changes and conduct more safety studies after several medicines, including Merck & Co.’s Vioxx, were pulled off the market due to safety risks.

Meanwhile, the report issued by the Institute and the FAA ban on Chantix use comes months after the FDA revealed that the connection between Chantix and serious psychiatric problems is "increasingly likely."  In the US, 34 Chantix users have reportedly committed suicide.  According to an FDA November 20 Early Communication, its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.


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