By On February 5th, 2008

Suicide risk among users of Chantix?

The FDA has confirmed 39 suicides (34 U.S.) among those that are using a new stop-smoking drug called varenicline (Chantix). In addition to the suicides, 420 reports of mood changes ranging from suicidal thoughts, anxiety, depression, and nervousness have been received. The drug, which has been used by approximately five million people since it was released in May of 2006, works by blocking the alpha4-beta2 nicotinic receptor in the brain.

The FDA has yet to confirm a causal link between the events and the drug itself. Additionally, the FDA still confirms their previous position that the smoking-cessation affects of the drug may outweigh the risks. Pfizer has issued new warnings on the drug’s label and in their commercial advertising for the drug.

Action Point: Physicians should carefully monitor the behavior of patients using the drug. Additionally, any deviation from normal emotions or thoughts when using the drug should be reported to a physician.

The following is an excerpt of an article from Medpage Today that reviews the FDA’s findings:

The FDA said today it has confirmed 39 suicides — 34 of them in the U.S. — among persons using the smoking-cessation drug varenicline (Chantix).

Overall the FDA said it has 420 confirmed reports of mood changes, including anxiety, nervousness, depressed mood, tension, and suicidal behavior or suicidal thoughts. Some of the reports have been from people taking the drug even though they have not yet quit smoking.

Moreover, the FDA said that although most of the symptoms were reported by patients using the drug, it has also confirmed cases where symptoms arose after the drug was stopped.

Nonetheless, the FDA reiterated its previous position that the drug was an effective smoking-cessation agent. At a press briefing, Bob Rappaport, M.D., director of the FDA’s division of anesthesia, analgesia, and rheumatology products, said those benefits might outweigh the risks.

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