Abstract
EMERGING EVIDENCE SUGGESTS THE smoking-cessation drug varenicline is among a growing list of medications that might cause serious psychiatric adverse events. A new analysis by the US Food and Drug Administration (FDA) adds to evidence that varenicline might be associated with an increased risk of suicidal thoughts and behavior, including among patients with no psychiatric history. The results, which were published in January, follow warnings from the agency that such a link is likely, as well as label changes noting a possible risk. The latest findings emphasize the importance of physicians monitoring patients taking varenicline for such adverse events. They also raise questions about how well new drugs are being screened for unwanted psychiatric effects. Continued reports of crashes and other serious adverse events among patients taking this drug also have raised concerns about other possible risks.
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