Pfizer's ($PFE) controversial smoking-cessation drug Chantix will continue to be stuck with a black-box warning label at least until late next year, assuming the U.S. Food and Drug Administration follows the recommendations of its experts. If so, that's likely the earliest the drug giant can make its case again to soften the labeling language.
On Thursday, an advisory panel for the regulatory agency voted to hold fast on maintaining the FDA's most severe warning label on the product, which has been reported to trigger suicidal depression, intense anger and other psychiatric troubles. Those claims began to surface soon after Pfizer launched the stop-smoking drug in 2006.
Still, the panel said it would take another look at its decision once data from a Pfizer postmarketing study on Chantix becomes available. That study involves about 8,000 people and is designed to compare the neuropsychological side effects of Chantix and two other smoking-cessation treatments. Data from the study will be available late next year, Reuters reported.
"I'm hoping the data confirms all the information we already have today," Steve Romano, a senior vice president with Pfizer, told the news agency.
Alarmed by the side effects being reported and additional data, the FDA slapped a black-box warning on Chantix in 2009, warning consumers about the possible psychiatric side effects that included hostility, agitation, depressed mood, and suicidal thoughts or actions.
The label and news reports quickly eroded Chantix sales, which have dipped by $648 million this year, slightly off from 2013--and significantly down from $846 million recorded in 2008. Plus there were the lawsuits. Last year, Pfizer paid out more than $275 million to settle thousands of them alleging that Chantix triggered suicides, suicidal thoughts and other psychiatric problems.
In late 2011, based on new study data, the FDA said that the drug didn't appear to increase the risk of psychiatric hospitalization. Yet, the agency decided to affirm its stance that the black-box warning was still necessary.
- see the Reuters story
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