Anti-Smoking Drug Chantix Causes Suicidal Thoughts And Drastic Changes In Behavior

Xinhua
Nov. 26, 2007

The U.S. Food and Drug Administration on Tuesday issued a warning about Pfizer Inc's anti-smoking drug, Chantix, amid reports of at least one death, and suicidal thoughts and behavior linked to the medication.

An early agency assessment "reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation (thoughts) and changes in emotion and behavior within days to weeks" of starting treatment, the FDA said in a posting about the new review.

The FDA has been under increased scrutiny from lawmakers and consumer groups for not communicating safety problems in a timely manner, and has started alerting the public earlier about a review, even if it has not come to a conclusion.

Many drugmakers claim the agency is taking a tougher stance on safety following the 2004 withdrawal of Merck & Co Inc's arthritis drug, Vioxx, and amid recent safety concerns about GlaxoSmithKline Plc's diabetes drug, Avandia.

Pfizer, the world's biggest pharmaceutical company, reported revenue of 241 million U.S. dollars for Chantix in the third quarter of 2007. That is significant, but still not one of its major drugs. It recently launched an ad campaign touting the drug, which it began selling last year.

The FDA stressed the warning "does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue."

Adverse event reports following a drug's approval are voluntarily submitted to companies by consumers and doctors and are a very rough indicator of any potential trends, a Pfizer official said.

Doctors are advised to monitor patients taking the drug for changes in behavior and mood, the FDA said.