Take five, and smoke 'em if you got 'em:
"FDA: little evidence to drop Chantix boxed warning" AP October 15, 2014
WASHINGTON — Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior.
The twice-a-day tablet has carried the Food and Drug Administration’s strongest warning label, known as a black box, since 2009 following reports of suicidal tendencies, hostility, and depression among some patients.
(Blog editor puts out cigarette)
But the New York drug maker has asked the FDA to drop the boxed warning, pointing to recent studies and analyses suggesting there is no difference in psychiatric problems between people taking Chantix and those taking other smoking-cessation aids.
The FDA will put the issue to a panel of outside experts on Thursday. But in briefing documents posted online Tuesday, the agency notes that there is little precedent for removing such a warning from a prescription drug.
Further, staff scientists say they have ‘‘concerns about the validity’’ of data submitted by Pfizer, including five company-sponsored studies that measured suicidal tendencies based on a questionnaire. Other large studies conducted by outside groups also provided ‘‘evidence of insufficient quality to either rule in or rule out increased risk of suicide.’’
FDA scientists note that Pfizer was previously required to conduct a large, comprehensive study of psychiatric side effects among patients taking Chantix versus those taking another popular antismoking medication, bupropion. Those results, which are expected to be completed in about a year, should be considered as part of any decision to remove the drug’s black box, the agency reviewers write. Despite that opinion, FDA will ask a panel of psychiatric and drug safety experts to vote on whether to remove the boxed label.
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