The Investigators

DALLAS (CBS 11 / TXA 21) ― A CBS11 investigation into new data from the US Food and Drug Administration is showing more serious problems with the anti-smoking pill Chantix.

Now, a consumer watching dog group is calling for a black-box warning label to be placed on Chantix. The warning is designed to highlight serious problems with a drug.

Public Citizen, a group founded by Ralph Nader, feels the FDA should order the drug manufacturer, Pfizer, to put this stronger labeling on the medicine to warn of serious side effects like depression and suicidal thoughts that may be associated with the drug.

Last week, CBS11 downloaded a freely available database and did something the government doesn't routinely do for the public, crunch the data to learn more about the adverse effects of the anti smoking pill Chantix. The data spans the first 9 months of 2007, which is the most recent data the government has made available.

The number of adverse events for Chantix rose from nearly 700 in the first 3 months, to a total of 3,700 at the end of the nine-month period.

Reports of attempted suicide went up from zero to a total of 18. The data shows reports of suicidal thoughts almost doubling every 3 months in 2007.

Scott Mullins said he suffered from suicidal thoughts after taking Chantix. "I said, 'You know, Dr. Kevorkian is out of jail.' I was very serious, not about seeing Dr. Kevorkian, but about the same result about seeing Dr. Kevorkian," said Mullins.

Chantix user Becky Moser said she had a similar experience with "crying and depression." When questioned about having suicidal thoughts while on the anti smoking pill, she stated "yes."

In an email to us, Pfizer questioned the reliability of the FDA's data stating in part, "often these reports lack sufficient medical information. It is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure" based upon this data.

But Dr. Sidney Wolfe of Public Citizen points out the FDA data shows an increase in adverse events in early 2007, before the well-publicized death of Dallas musician carter Albrecht, who died in September after taking Chantix. It's believed the pills made him exhibit bizarre behavior resulting in his death.

In January 2008, Pfizer updated the Chantix label. It warns all patients be observed for potential neuropsychiatric symptoms, including among other things, suicidal behavior.

Dr. Wolfe of Public Citizen stated that about two-thirds of the time it asks for a black box warning on a drug, the FDA ends up issuing the warning.

UPDATED PFIZER STATEMENT ON CHANTIX

We believe the current Chantix label accurately reflects the efficacy and safety profile of the product and communicates appropriate information to healthcare providers and patients. As you know, in January 2008, Pfizer, in collaboration with the FDA, updated the Chantix label in the U.S. adding a warning that all patients attempting to quit smoking with Chantix should be observed for potential neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. The EU label was updated in February 2008 to reflect this information* The label was updated to provide healthcare providers and patients with important medical information about Chantix, which they should include in their discussions about smoking cessation treatment options. By heightening awareness of these post marketing events and facilitating this discussion, patients and doctors can play an important role in mitigating potential risk and ensuring the full benefits of Chantix can be realized.* It is important to remember that cigarette smoking is associated with significant morbidity and mortality. Smoking is the leading preventable cause of disease and premature death in the United States, with more than 438,000 U.S. deaths annually attributable to smoking.

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