Trying to quit smoking and thinking of taking the prescription medication Chantix? Using the smoking cessation drug might sound like a good idea. After all, a Food and Drug Administration advisory panel met earlier this month and recommended the agency remove its black box warning—the strongest warning it can offer—about the drug causing an increased risk of serious mental problems, such as suicide and depression. But that doesn’t mean the drug has a clean bill of health. It can trigger other serious problems, including heart attack and a higher risk of accidents while driving. So if you are trying to stop smoking, our medical advisers still recommend starting with safer options first, such as counseling and nicotine replacement patches, gums, or lozenges.

“Consumers should remain wary of Chantix, which should stay a last option,” says Marvin Lipman, M.D., Consumer Reports’ chief medical adviser. 

Consumer Reports Best Buy Drugs has long advised against Chantix as a first-choice treatment to stop smoking because of its association with thousands of reports of people having homicidal and suicidal thoughts, aggression, and delusions after taking it, according to reports compiled by the nonprofit Institute for Safe Medication Practices. The FDA required the manufacturer Pfizer to do a clinical trial to determine whether those side effects were actually triggered by Chantix. The trial, called EAGLES, found that Chantix did not increase the risk of those problems. But the FDA’s internal reviewers had serious doubt about that study's findings, saying that cases of depression and other serious illnesses were underreported.

The committee also noted that there were a number of cases of people who reported related symptoms and were even hospitalized, but investigators recorded that the person was not ill. 

However, a majority of the advisory panel convened by the FDA did not agree and voted to remove the black box warning because they didn’t think the evidence supported such a strong caution. Yet several of the experts stressed that they didn’t want their vote to be interpreted as though there were no concerns about the safety of the drug.

“The agency should do whatever it can to prevent the impression that the removal of the black box warning is an endorsement of the safety,” said panel member Tobias Gerhard, Ph.D., a pharmacoepidemiologist at Rutgers University in New Brunswick, N.J.

Safer Ways to Kick the Smoking Habit

Stopping smoking is especially important because smoking increases the risk of blood clots and heart disease, elevates blood pressure, and damages the lungs. Counseling (in person or over the phone), self-help materials, and nicotine replacement options, such as gum, inhalers, lozenges, patches, and nasal sprays, have all been shown to help people stop, according to the U.S. Preventive Services Task Force. And they all carry less risks than Chantix does.

What works even better is a combination of a nicotine replacement product with counseling. Side effects triggered by the nicotine replacement products include headaches, nausea, and indigestion, and insomnia (but that sleeplessness usually goes away after the first few days).

If after trying those you are still struggling, then Chantix might be worth a try. But if you experience depression and/or have thoughts of suicide after taking it, contact your doctor right away. 

Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).