From Reuters: An anti-smoking drug sold by Pfizer Inc will carry more prominent warnings that patients be monitored for unusual activity including agitation, depression and suicidal behavior, the company said on Friday.The world's largest drugmaker said it worked with the U.S. Food and Drug Administration to update an earlier label change enacted last year for its drug Chantix.
The new label offers a similar recommendation to monitor patients, but the language is more prominently located to better get the attention of doctors, Pfizer officials said.
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The revised section is not a "black box," a warning reserved for what the FDA deems the most dangerous potential adverse events.
It directs doctors to observe patients on Chantix for "serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior," according to Pfizer.
In November, the FDA issued an early warning after receiving reports of suicidal thoughts and behavior, and at least one death, potentially linked to the medication.
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