Pfizer won a crucial battle in its quest to widen the market for its Chantix smoking cessation pill late Wednesday when a federal advisory panel recommended that a serious warning about neuropsychiatric side effects should be removed from the product labeling.
The recommendation followed a two-year effort by the drug maker to remove a so-called Black Box warning — the most serious type of health alert — that indicated Chantix could cause patients to experience such side effects as suicidal thoughts and hostility. An earlier attempt in 2014 failed when an FDA panel voted to recommend that the warning should remain intact.
The side effects have plagued the drug ever since it was approved a decade ago and endured horrendous publicity about violent or suicidal behavior. As a result, Pfizer spent hundreds of millions of dollars to settle numerous lawsuits and sales for the pill — once pegged to become a blockbuster — have plateaued, sliding from $846 million in 2008 to $671 million in 2015.
In making its recommendation, a US Food and Drug Administration advisory panel reviewed the results of a study that was released earlier this year and found that Chantix does not appear to increase the risk of suicidal behavior. An FDA medical review team had cast doubt on the study due to problems with collecting and analyzing side effect data as well as ties some investigators had to Pfizer. [Read: “FDA Reviewers Reveal Pfizer's Questionable Interpretation of Chantix Safety Trial Results”; http://sco.lt/9FgMsb]
One consumer advocate expressed surprise that a majority of committee members voted to remove the warning, given questions about the study. Sammy Almashat of Public Citizen, the consumer advocacy group, noted the study included composite outcomes of both serious and milder symptoms, including irritability and agitation, which normally occur in people who are trying to quit smoking.
“A Black Box warning has been rescinded very few times in the past,” he said. “This could set an ominous precedent. If the FDA rescinds, a company can now go to the agency with a substandard post-marketing trial, point to Chantix and demand the same outcome. We’re worried that if the FDA follows through with the recommendation, that this will become a new standard for removing a black box.”
Also read: “Consumer Groups Petition FDA to Keep Black Box Warning for Pfizer’s Chantix”; http://sco.lt/7VBCPR