FDA panel backs removal of warning on Pfizer's Chantix
- After a contentious back and forth with critics at a meeting on Wednesday, an independent advisory panel to the Food and Drug Administration voted in favor of removing the black box warning from Pfizer's smoking cessation drug Chantix.
- The joint panel convened members of two committees, he Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee, to review removal of the warning.
- Ten out of 19 members voted to remove the warning from the label, while five voted against removing the warning and four voted in favor of modifying the language of the label.
Pfizer's Chantix (varenicline) has stirred up controversy over its safety since approval in 2006, even as it has helped many people quit smoking after previous failed attempts.
The drug could be a key weapon in fighting and preventing cancer, but neuropsychological effects have kept sales of the drug at a nominal level. Pfizer has been trying to persuade regulatory authorities to remove the black box warning on the label, which has dissuaded use. With the positive vote on Wednesday, the big pharma got one step closer to doing so.
The advisory committee discussed the results of the 8,000 member EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial. While they commended the company on the trial design, some panelists still had questions about the results.
Ultimately, however, most panelists agreed that the benefits outweighed the risks.
"It’s the right thing to do from a public health perspective," said one panelist who voted in favor of removing the warning, according to Tarius SAC Tracker, a service that track's advisory committee meetings.
"Labeling should state that while risks may be present for all patients, they are potentially enhanced for patients with psychiatric history," added another panelist who voted in favor of modifying the label.
The advisory committee meeting was just the first hurdle for Pfizer. The decision is now in the hands of the FDA. Panel recommendations are not binding, although the regulator usually follows the panel's decision.
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