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Smoking Cessation Drugs to Get Boxed Warning
The smoking cessation drugs bupropion (Wellbutrin, Zyban) and varenicline (Chantix) must now carry boxed warnings on their labels to alert patients of the risk for serious neuropsychiatric symptoms, according to the FDA.
Physicians should help patients understand the benefits of quitting smoking versus the risks posed by these drugs, the agency says. The FDA advises patients with these symptoms to stop taking the drugs immediately: changes in behavior, hostility, agitation, depression, and suicidal thoughts or behavior.
(Unfortunately, irritability, anxiety, depression, and difficulty sleeping are also common symptoms of nicotine withdrawal.)
The FDA warns that patients with a preexisting psychiatric illness may experience worsening of symptoms while taking bupropion or varenicline.
LINK(S):
FDA alert (Free)
FDA's Drug Safety Newsletter, including details of bupropion and varenicline review (Free PDF)
Previous Physician's First Watch coverage of varenicline and neuropsychiatric symptoms (Free)
Published in Physician's First Watch July 2, 2009
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