Chantix: There are better ways to stop smoking

As if smokers don't have it hard enough, it turns out that a new drug heavily advertised as a way to help smokers kick the habit poses serious health risks, ranging from aggressive behavior to suicide. And, as we reported previously, cigarette makers aren't making quitting any easier. After years of decline, adult smoking rates have recently hit a plateau, possibly because tobacco companies have ramped up their marketing campaigns and cigarettes these days appear to have more nicotine than they used to.

The new risks, detailed in a study released on May 21st by the independent Institute for Safe Medication Practices, focus on the anti-smoking drug varenicline (Chantix). Last year Pfizer spent nearly $64 million advertising the drug directly to consumers, with considerable success. Sales of the medication reached close to $765 million in 2007. But based on the new report and other recent concerns, we think everyone taking Chantix should talk to their doctor about safer alternatives.

The Institute's findings help clarify the risks of Chantix, which the Food and Drug Administration has previously hinted at. The new report links the medication not only to aggression and suicide but also an increased risk of falls, potentially lethal heart problems, seizures, skin reactions, psychosis, and vision problems. The Institute found that the FDA received 988 reports associated with use of the drug in the last quarter of 2007, more than with any other drug during that same time period.

Those concerns underscore several issues we've long emphasized:

• Smokers need safe, effective ways to quit. The smoking cessation strategy we recommend begins by talking with a doctor or a specialist counselor, and taking medications if necessary. Over-the-counter and prescription nicotine replacement products are proven to be safe. The antidepressant bupropion (Zyban and generic) also seems to help by stimulating some of the same brain chemicals as cigarettes.  Be cautious, however, if you take both drugs, since the combination can make blood pressure spike.
• View all new medications with caution. The experience with Chantix over the past year is a powerful reminder of the risks new drugs can pose when they are used by a larger and more diverse population than was possible in pre-approval studies. Stick with tried-and-true medications unless a new drug offers clear advantages.
• If you experience a drug side effect, report it to your doctor and the FDA. Call your doctor if you experience any unusual symptom soon after starting a drug. You can also report suspected adverse drug events directly to the FDA's MedWatch program.

We think that Congress should ban consumer advertising of newly-approved drugs for the first three years in order to be more certain about their safety. Our patient-safety advocates also want the FDA to make it easier for people to report their side effects. Find out more about our Prescription for Change campaign.