Pfizer Inc. has started a huge marketing blitz to save the reputation of its once-promising anti-smoking drug <"http://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix.Â Chantix has been recently linked to a variety of ills, including suicidal thoughts and behavior, heart problems, seizures and traffic accidents.Â But Pfizer has a lot riding on Chantix – the drug is its second biggest growth driver – so the drug maker is making a desperate effort to downplay Chantix side effects.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.Â Some analysts had estimated that Chantix sales could reach $2.28 billion by 2012.
But the drug has been the subject of disturbing side effect reports. In the US, 34 Chantix users have reportedly committed suicide.Â According to an FDA Nov. 20 Early Communication, the agency said that its preliminary assessment revealed that 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.Â In February, the FDA said â€œit appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.â€ The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.
Last Tuesday, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA.Â The report specifically citedÂ 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes.Â There were also reports of traffic accidents and falls linked to Chantix.Â As a result of the Instituteâ€™s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers.Â Earlier this week, the Federal Motor Carrie Safety Administration said that “â€¦ it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driverâ€™s ability to safely operate a commercial motor vehicle.â€
To quell Chantix safety concerns, Pfizer is preparing to run ads in the country’s five largest newspapers today, including the New York Times and Wall Street Journal, a company spokesperson told Bloomberg.com.Â According to Bloomberg.com, the new ads will feature a letter from Pfizer Chief Medical Officer Joe Feczko telling readers about the dangers of smoking and the benefits of Chantix. It says 44 percent of patients who took Chantix in its clinical trials quit smoking after 12 weeks. The ads also tell patients to stop taking the drug if their mood or behavior changes.
Pfizer is also in the process of sending letters to 300,000 health-care professionals and plans to hold briefings with reporters. In addition, the company will start running television commercials in early June that talk about the importance of quitting smoking without naming Chantix.Â Pfizer will also submit “opinion” pieces to newspapers meant to address “misconceptions” about the drug.
It is little wonder that Pfizer is in such a panic over Chantix.Â Bloomberg.com reports that the drug has been touted as a way to help offset $12 billion in sales that the company’s Lipitor cholesterol medicine will begin losing to generic competition in 2010.
How much this campaign will help bolster Chantix remains to be seen.Â The controversial drug is under fire on several fronts.Â Norman Edleman, chief medical officer for the American Lung Association in New York, told Bloomberg.com last week that doctors are now using the pill only when other treatments fail. The FDA said last week it will be reviewing all Chantix side effect reports, but is focusing on psychiatric side effects first.Â Congress is also taking a look at Chantix, and the FDA is scheduled to brief the staff of Republican Senator Charles Grassley about Chantix on June 3.Â Grassley recently sent the agency a letter questioning the FDA’s response to Chantix side effects reports.