Pfizer finally convinces FDA to pull black-box warning on Chantix for psychotic side effects

FDA officials have removed the black-box warning from Pfizer’s stop-smoking med Chantix after a postmarketing study showed that it wasn’t associated with a higher rate of severe neuropsychiatric events.

Seven years after safety concerns altered the trajectory of Pfizer’s stop-smoking med Chantix, the FDA has pulled its black-box warning from the drug’s label.

FDA officials removed the warning after weighing data from the EAGLES postmarketing study showing that Chantix wasn’t associated with a higher rate of severe neuropsychiatric events. Another update notes that Chantix has a higher efficacy than GlaxoSmithKline’s Zyban or a nicotine patch, according to a statement.

The announcement follows a majority vote by FDA panelists in September to recommend pulling the warning after they reviewed the global study data. Now, after years of working to address the concerns, Pfizer is “pleased” with the decision, according to Chief Medical Officer Dr. Freda Lewis-Hall. 

Now, the company can expect a boost for a med that last year brought in $671 million around the world.

Before this attempt, Pfizer pushed in 2014 to get the severe label warning pulled, ultimately falling short as only one FDA panelist supported its removal.

Following the EAGLES analysis, the FDA also removed language detailing “serious mental health side effects” from Zyban’s label warning, though that med will continue to feature a black box. GSK, which doesn’t “actively promote” its drug, did not request that the box be removed, according to a spokesperson.

In its statement, the FDA said the “risk of serious side effects on mood, behavior, or thinking … is lower than previously suspected,” though still present in the stop-smoking drugs.

Pfizer’s Chantix had been hailed as the company’s fastest launch before safety concerns led to the FDA’s black-box warning back in 2009. The company continues to steadily spend to support its med, with Chantix coming in at number 9 of 2015’s TV advertising at $68.5 million. Pfizer spent $103 million overall in 2014 to advertise the drug.

Back in 2013, the company laid out $273 million to settle thousands of legal cases tied to the drug. Pfizer launched Chantix in 2006.

Suggested Articles

With a seven-figure opioid settlement in the works and its generics unit facing bankruptcy, Mallinckrodt will lean on Acthar Gel for future growth.

After a draft report last November, ICER's final findings on Allergan and Biohaven migraine medicines are more favorable.

As part of a multi-year asset offload, AstraZeneca has divested most of its global rights to constipation med Movantik to RedHill Biopharma.