Stop-smoking drug tested despite adverse effects

Soon after the quit-smoking pill Chantix debuted in 2006, the U.S. Food and Drug Administration began receiving reports of severe psychiatric disturbances in people taking it.

Experts who analyzed the FDA's database of "serious adverse events" found Chantix was suspected in more cases of violence than any other prescription drug. It also generated more reports of suicide, self-injury, and depression than any other smoking-cessation therapy.

Despite this troubling link - which has led the FDA to require prominent warnings on the Chantix package insert - researchers at the University of Pennsylvania and other medical centers are now testing it in people who may be especially vulnerable to such problems. These include alcohol, cocaine, and methamphetamine addicts.

Testing is warranted, experts say, because Chantix is generally safe; millions worldwide have used it with no big complaints. And some addictions are so devastating that the benefits of a medication that promotes abstinence would far outweigh the risks of possible side effects.

No drugs have been approved to treat cocaine or meth addiction, despite years of research.

At the National Institute on Alcohol Abuse and Alcoholism, which is also testing Chantix, principal investigator Joanne Fertig said, "Alcoholism is a life-threatening disease. I think it's imperative for us to keep looking and screening medications that are out there."

Still, scientists conducting these pilot trials - mostly funded with federal grants - realize that using Chantix in high-risk patients is ethically and medically dicey.

As a precaution, the studies exclude addicts with suicidal tendencies or a mental illness such as bipolar disorder. However, many smokers who reportedly developed psychiatric problems while on Chantix had no history of it.

At the University of California, Los Angeles, where Chantix is being tried in meth users, physician Keith Heinzerling said, "It's a delicate balance between the ethics of exposing volunteers and finding answers to questions we need to answer."

Researchers are encouraged that in about a dozen studies under way or finished, patients have had no major psychiatric events - so far, anyway.