("Pfizer Adds Warning To US Labeling On Chantix," published at 12:53 p.m. EDT, incorrectly described where the warning on skin reactions appears on the product label, in the penultimate paragraph. A corrected version follows.)
DOW JONES NEWSWIRES
Pfizer Inc. (PFE), responding to Food and Drug Administration concerns, said Wednesday it has added a warning about severe neuropsychiatric events and other possible side effects to the U.S. labeling of its Chantix smoking-cessation drug.
The warning is another blow for the three-year-old drug, which suffered a 36% decline in first-quarter sales amid publicity surrounding potential psychiatric side effects. Pfizer has said it may run trials to see if the drug helps prevent heart attacks in smokers.
"The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," said Briggs W. Morrison, senior vice president, primary care development group.
The company said some information on the side effects have been on the label since November 2007. The boxed warning instructs health-care providers to observe patients for their appearance.
The updated label also warns of possible skin reactions.
Pfizer shares were down 1.1% to $14.84 in recent trading. The shares have risen by more than one-quarter in the past four months.
-By Jay Miller, Dow Jones Newswires; 212-416-2355; jay.miller@dowjones.com