PFE Pfizer Inc

Pfizer Inc. said two federal advisory panels have recommended removing the most serious warnings on its Chantix smoking cessation pill, clearing a major hurdle in the pharmaceutical giant's push to lessen concerns about using the medicine.

The move comes out of a joint meeting of the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee. The panels have recommended to the FDA that a so-called Black Box warning—noting the risk of psychiatric side effects, such as suicidal thoughts and behavior—should be removed from the medicine. A boxed warning appears on a prescription drug's label, calling attention to serious or life-threatening risks.

Pfizer said the FDA has to make a decision related to the advisory committees' findings; a representative for the regulator couldn't be reached immediately for comment.

A move by regulators in the U.S. to remove the label, issued in 2009, would follow a similar decision earlier this year by Europe's main drug regulator to lift the suicidal risks warning. Regulators in Europe and the U.S. have reviewed a study that found users of the drug had no elevated risk of suicides, suicide attempts or suicidal thoughts.

The treatment once was seen as a blockbuster but since has sputtered. Shortly after Chantix was approved in 2006, the pill became associated with stories of suicide and violence, which damped use.

The smoking-cessation treatment represents a relatively small portion of the company's revenue. Last year, it brought the company $671 million in revenue compared with Pfizer's total revenue of $48.85 billion.

Write to Joshua Jamerson at joshua.jamerson@wsj.com

(END) Dow Jones Newswires

September 14, 2016 21:15 ET (01:15 GMT)

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