FDA Targets Anti-Smoking Drug: It’s Pushing for Warnings on Psychiatric Side Effects in Some Patients Who Use Chantix.

By Jennifer L. Boen, The News-Sentinel, Fort Wayne, Ind.

Feb. 6–The U.S. Food and Drug Administration is calling for additional warnings on side effects of what is considered the most effective — and prescribed — drug used today to help people quit smoking.

The FDA is ramping up its November “early communication” to the public and health care providers about Chantix, citing side effects that include agitation, depressed mood and suicidal thoughts.

“There is some evidence of increasing concern,” said Dr. Don Marshall, a psychiatrist and addiction medicine specialist at Park Center Inc. in Fort Wayne. “The FDA may put a ‘black-box’ label on it.” Black-box warnings are found on antidepressants that increase suicidal tendencies in children and adolescents who take them.

Patients should tell their health care provider about any history of psychiatric illness before starting Chantix, which can worsen an existing condition, even one under control, according to the FDA.

A complicating factor with Chantix, Marshall said, is “there is a higher incidence of depressed people who smoke. When these depressed people stop smoking, they’re basically stopping their antidepressant (the nicotine).”

But everyone should take caution, he said. Psychiatric symptoms also are found in people with no previous history of mental illness. Chantix also can evoke disturbing and terrifying dreams.

Kathleen Gerhart, coordinator of Lutheran Hospital’s Tobacco Intervention Program, said the drug works for many of her patients, but that more and more are asking about its side effects. As a preventive measure, new patients are screened for depression and then at each visit every other week. What concerns her and Marshall is whether family physicians are screening for depression before prescribing Chantix.

Presently, the information sheets inside the Chantix box contain little information on psychiatric symptoms, Gerhart said.

The drug’s Web site lists “commonly occurring” side effects that include nausea, sleep disorder, gas, sleeplessness, constipation, headache and loss of taste. No mention of psychiatric symptoms is made, but FDA officials say at least 100 complaints have been received. The August 2007 American Journal of Psychiatry outlined several cases of serious psychiatric illness that developed in patients after they started Chantix.

While the FDA continues its investigation and works with Pfizer to increase warnings to patients, those who have seen how effective the drug is hope it remains on the market.

“It really does help people,” Gerhart said, whose program sees “the toughest of the toughest” patients attempting to quit smoking. “I do not see them recalling it. I hope not.”

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