FDA Reviews Chantix Side Effects

The agency is looking into reports that the Pfizer smoking-cessation drug causes erratic behavior and suicidal thoughts.
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The Food and Drug Administration said on Tuesday that it's reviewing reports of erratic behavior and suicidal thoughts in patients taking

Pfizer's

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smoking-cessation drug Chantix.

The FDA is currently evaluating cases that Pfizer submitted. "A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment," according to an agency note to health care professionals. But the agency said the association between these events and recently approved Chantix isn't clear.

The agency said it asked Pfizer for additional cases that might be similar to a highly-publicized case of erratic behavior that led to death of a patient using the drug in an instance when alcohol reportedly played a part, and it's evaluating Pfizer's response.

The FDA is also evaluating reports of drowsiness that affected patients' ability to drive or operate machinery while taking Chantix. The agency urged doctors to monitor patients on Chantix for changes in behavior and mood, and noted patients should be cautious and report changes until they know how the drug may affect them.

Shares closed Tuesday's session up a penny at $22.72 but were slipping 7 cents, or 0.3%, to $22.65 in recent after-hours trading.