Pfizer Moves Closer to FDA Removal of Suicide Warning on Chantix
15 September 2016 - 11:30AM
Dow Jones News
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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