On Monday, the Food and Drug Administration (FDA) announced that it wouldn’t remove the black-boxed warning about possible suicidal behavior and depression from the Pfizer’s anti-smoking drug Chantix. The company also reported several updates to the labeling including unusual behavior linked to taking the drug with alcohol.
The FDA explained that its current boxed warnings on Chantix are the result of a compressive review on the company’s findings that had revealed that its drug wasn’t linked to any psychiatric disorders.
In 2011, Pfizer announced that it was carrying an extensive study on possible side-effects of its anti-smoking drug, but the preliminary results weren’t scheduled to be released until 2017. However, patients taking Chantix had experienced behavioral changes since 2007. But no one seemed to listen.
Even the FDA said four years ago that a couple of federally funded studies didn’t reveal any link between Chantix and psychiatric side-effects such as suicidal thoughts and chronic depression.
People had no history of psychiatric disorders
But in 2009, the FDA changed its mind and asked the big pharma group to change Chantix’ labeling and introduce bold-letter suicide warnings after it had received about 500 reports about suicidal thoughts, attempts, and completed suicides. More than 400 reports were issued by U.S. patients, while 34 completed suicides involved U.S. users. Only five cases were recorded overseas.
Back then, the FDA concluded that there was no cause-and-effect link between Pfizer’s smoking cessation drug and an increased suicide rate, but people needed to be cautious. Moreover, suicidal behavior was reported by patients who had no histroy of psychiatric disorders.
In 2008, the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products expressed its concerns on a number of “compelling cases” that were probably linked to Chantix exposure. The FDA described the findings on the widely used smoke-cessation product as “very concerning” and urged Pfizer to update the Chantix labels.
But on Monday, the agency announced more updates among which the recommendation about not drinking alcohol while on Chantix is the most notable. Several reports have shown that the mix between alcohol and Chantix lead to increased aggressiveness, bizarre behaviors, and even suicidal tendencies.
Several years ago, the Federal Aviation Administration bared its pilots and air traffic controllers from taking the drug because there were suspicions that it might interfere with their work.
The FDA requested an updated labeling because it had reviewed Pfizer’s studies and analyses and found that there were many gaps in the research. Pfizer concluded that Chantix didn’t lead to psychiatric disorders in its users, but FDA thought otherwise.
The FDA scolded Pfizer because its studies didn’t involve all types of psychiatric disorders and even imposed limitations that made it hard for the agency’s investigators to draw “reliable conclusions.”
In 2014, the drug maker asked the FDA to allow it to remove the bold-letter warning from the Chantix label. Back then, the company based its request on the above mentioned studies and analyses.
But the FDA chose to maintain the warning since a panel of independent experts asked it to do so in October. According to the panel, the warnings should remain on the label until further studies are conducted. Pfizer have already announced that it would complete a larger study on the psychiatric side-effects by the end of this year.
However, many medical journals and trials debated Chantix’s safety, while a cohort of reports on suicidal behavior and other disorders flooded the FDA.
Chantix’s label currently advises patients to stop taking the anti-smoking drug if they feel agitated, depressed, have suicidal thoughts or experience any behavioral changes. Physicians are also advised to carefully weigh the benefits and drawbacks of the drug when prescribing it to their patients.
Chantix was approved in 2006, but the FDA updated its labeling several times. The warnings introduced in 2009 are highlighted by a black box. Researchers explained that the suicidal behavior and depressive mood may be linked to the way Chantix interferes with brain’s activity.
The drug blocks the receptors that release a hormone linked to the “feel-good” feeling triggered by nicotine use. By doing so, smoking becomes less addictive and smokers find it easier to quit since no compensations results from it anymore.
But there’s a price to pay for the miracle drug – many become depressed and even suicidal.
Too many side-effects
Some patients reported that although they had no history of depression they felt the urge to take their own lives. Psychotic episodes were also reported, while anxiety and depressive mood are regular side-effects. Other people experienced feeling angry, impatient, and having problems concentrating.
“Two weeks after being on Chantix my emotions have been off the scale: from crying to yelling to feeling totally helpless. I have, twice before, quit smoking cold turkey and NEVER felt so depressed,”
one woman reported.
Other patients reported that they also experienced nausea, back pains, hives, loss of energy, apathy, personality disorders and mood swings, or agitated sleep and vivid dreams while taking the drug.
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