Pfizer Inc. was unsuccessful in convincing the US Food and Drug Administration to remove the black-box warning on its smoking cessation drug Chantix. Also known as varenicline, Chantix was first approved in May 2006 and is one of Pfizer Inc.’s most controversial products and has a few severe side effects such as agitation, depression, erratic behavior and suicidal thoughts.
Yesterday a majority of an advisory panel voted that the health regulator’s strongest warning label—which first appeared in 2006–remain on the treatment. Specifically, the vote was 11 in favor of keeping the existing warnings. Six proposed changes and one favored removal of the warnings.
Additionally, several panel members reportedly suggested adding “sleep disturbances” to the current warnings. The president of the National Center for Health Research, Diana Zuckerman, said the advisory panel’s decision “certainly showed a total rejection of the company’s position.” The US Food and Drug Administration first put a “black-box warning” — its most severe and restrictive warning — on the product in 2009, noting the drug’s negative neuropsychological effects.
The advisory panel did, however, agree to reconsider their vote after data from the pharma-company’s “post-marketing study” of Chantix becomes available. Pfizer Inc. is currently conducting a study of 8,000 subjects comparing Chantix’s significant neuropsychological side effects with a pair of competitor’s smoking-cessation treatments and a placebo. The results of the study are expected sometime during the third quarter of 2015.
Steven Romano, a Pfizer senior vice president, told the press: “We feel the boxed warning is no longer supported by the data we now have.” Analysts add that the enforced warning label retention will probably have little impact on the company’s sales or profits. In fact, Pfizer Inc. reportedly had at least a dozen drugs that had better sales figures than Chantix in 2013.
FDA: Pfizer Must Keep Warning On Chantix