Pfizer Inc., trying desperately to save the reputation of <"http://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix, is claiming the anti-smoking drug is safe – even for people suffering from mental illness.Â This, in spite of the fact that the Food & Drug Administration (FDA) is reviewing Chantix due to a number of serious side effects, including severe depression and suicide.
Chantix was supposed to be a blockbuster for Pfizer. It was approved in 2006, and was the first nicotine receptor partial agonist – meaning it blocks nicotine receptors in the brain – on the market.Â But there have been at least 34 reports of suicides related to Chantix in the US.Â According to an FDA Nov. 2007 Early Communication, the agency said that 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.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.
Then last month, 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 Carrier Safety Administration said that â€œâ€¦ 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€Â The report also led the FDA to announce another Chantix safety review.
Pfizer, which is counting on Chantix to be one it biggest growth drivers, has embarked on an aggressive campaign to prop up the drug’s image.Â The campaign includes advertisements in the country’s biggest newspapers, as well as a letter campaign to physicians.Â Pfizer will also submit â€œopinionâ€ pieces to the editorial pages of newspapers meant to address â€œmisconceptionsâ€ about the drug.
Yesterday, as part of that campaign, Pfizer held a roundtable discussion with members of the media.Â Representatives from Pfizer insisted Chantix is safe, and cited studies – which were paid for by the company – that found no suicide risk.Â One of the key points the company tried to make at the meeting was that depression – which is a risk factor for suicidal behavior – is not unusual in people who are trying to quit smoking.Â But some of the reports involving bizarre behavior in Chantix users – including that of musician killed when he tried to break down a neighbors door – sound a bit extreme to be typical of nicotine withdrawal.
Meanwhile, in an Associated Press interview, Pfizer Senior Medical Director Dr. Martina Flammer said Chantix is even safe for the mentally ill, although he suggested such patients inform doctors of their medical history.Â Pfizer also said it has funded grants to independent scientists to investigate severe adverse events of Chantix in patients with depression, schizophrenia and alcoholics.
But David Gonzales, co-director of Oregon Health & Science University’s Smoking Cessation Center and who led Chantix clinical trials, told the Associated Press that people with schizophrenia and other mental illness were deliberately excluded from those studies so that adverse events couldn’t be attributed to a pre-existing condition.