Chantix, Other Stop-Smoking Drugs Must Carry Stronger Warnings of Suicidal Thoughts, FDA Says

The Food and Drug Administration is cracking down again on Chantix, Zyban, and other smoking-cessation drugs by forcing them to carry prominent warnings about possible side effects, including suicidal thoughts, depression, and aggressive behavior.

The FDA just announced that it will now require the stop-smoking products to include so-called “Black Box” warnings on their packaging. Makers of the drugs must also further study the products to determine the extent of such severe side effects, the FDA said.

Chantix is made by Pfizer Inc. while Zyban is marketed by GlaxoSmithKline PLC. The products have been taken by at least five million people worldwide looking to kick their smoking habits.

Wellbutrin, an antidepressant with the same active ingredient as Zyban, already carries such a warning of serious side effects.

More Controversy for Chantix

When Chantix was approved in the United States in 2006, it became the first non-nicotine prescription smoking-cessation product to hit pharmacy shelves in a decade. The drug is known generically as varenicline and has been controversial since its launch.

U.S. health officials have blamed Chantix for at least 39 deaths and 500 reports of suicidal thoughts, severe nightmares, and sudden aggressive behavior among users.

Canadian officials recently ordered stronger warnings for the version of the drug sold there and throughout Europe under the brand name Champix.

In November 2007, the FDA announced it was reviewing dozens of reports of patient deaths and hundreds of reports of suicidal thoughts and behavior among Chantix users. The agency later warned Chantix users about the severe side effects in February 2008.

The Federal Aviation Administration prohibited its air-traffic controllers and pilots from taking Chantix while on duty because of the possibility of irrational behavior and blackouts.

Then, just last month, the FDA announced it was taking a closer look at Chantix, a review that apparently resulted in today’s announcement of tougher warnings on the packaging.

Drugs Are Still Effective, FDA Says

Still, the FDA said Chantix, Zyban, and similar smoking-cessation products are proven effective in helping smokers who want to quit and that just like any drugs, doctors and users should carefully consider the risks and benefits of treatment before taking them.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

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