An advisory panel of the American Food and Drug Administration has voted against an effort made by Pfizer Inc. to remove boxed warnings of neuropsychiatric side-effects on the label for Chantix, a smoking-cessation drug produced by the company.
Out of the assembled committee members, 11 voted in favor of maintaining the existing warnings, six suggested modifications and one voted in favor of removal. A discussion also commenced as several panel members suggested that sleep disturbances also be added to the warnings.
Although the FDA doesn’t have to follow such recommendations, it has agreed to wait for a study being conducted by Pfizer so as to properly reassess the issue. Researchers expect the study to be completed in 2015.
The drug in question, Chantix, was first approved in May 2006 by the FDA, and initial indications that psychiatric side-effects might arise stemmed from both cases reported to the agency and medical literature. Safety warnings were included on the label starting with 2008, and underlined suicidal thinking, altered behavior, agitation and depression as main concerns.
In 2009, the company modified the packaging and emphasized the seriousness of the issue by also mentioning mania, psychosis, hallucinations and paranoia among the possible side effects. However, since then, the pharmaceutical giant has examined data from countless studies and has come to the conclusion that the warnings no longer reflect the reality.
On the other hand, consumer groups argued that the warnings should be strengthened.
“We feel the boxed warning is no longer supported by the data we now have,”
Steven Romano, Pfizer senior vice president, said in an interview.
He told reporters that the study that Pfizer was currently running assessed the risk of psychiatric side effects in a population of 8,000 subjects taking either Chantix, another antismoking treatment or nothing at all.
Vareicline (or Chantix) was considered one of the pharmaceutical giant’s most promising drugs, effective in aiding smokers loose the habit. In 2006, after the FDA approved the substance, Pfizer totaled $883 million in sales.
However, soon after the FDA added the warnings to Chantix’s label in 2009, sales began to fall, totaling $648 million by 2013. In addition, the company also had to face hundreds of lawsuits following the appearance of those warnings.
Pfizer has been preparing a Chantix comeback and decided to settle all lawsuits claiming that Chantix had caused suicides. In fact, according to a securities filing, Pfizer settled “virtually all” the known lawsuits connected to the drug.