Consumer

Suicide Concern Tied To Anti-Smoking Drug In UK

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FORT WORTH (CBS 11 News) ― Tuesday, the Medicines and Healthcare products Regulatory Agency, the United Kingdom's version of the U.S. Federal Drug Administration, announced it has received troubling reports from patients using the drug Champix.

Champix is an anti-smoking drug manufactured by Pfizer. In the United States the drug is known as Chantix.

Some people reported having suicidal feelings while on the drug and the organization said it is monitoring the drug closely.

It has been on the U.K. agency's intensive surveillance list in for months.

Last week, cbs11tv.com broke the news that the FDA is investigating the anti-smoking pill here in the U.S. for reports of suicidal thoughts and aggressive and erratic behavior.

In September, CBS 11 was also first to report thousands of adverse reactions to the drug, discovered in the FDA's own database.

Watchdog groups question the drugs safety, but Pfizer insists it's safe.

Nearly 20,000 people in the U.K. have taken the anti-smoking pill and there are 839 reports of suspected adverse reactions to the drug.

There have been 16 reports of suicidal thoughts, but no reports of actual suicides.

Here in the U.S., the FDA recommends healthcare providers monitor patients taking the drug for behavior and mood changes.

Pfizer released their official statement to CBS 11. It reads as follows:
 
Pfizer, in collaboration with the U.S Food and Drug Administration, has updated the CHANTIX label to reflect post-marketing reports, among other modifications.

The adverse reaction section of the label was updated to include spontaneous post-marketing adverse event reports of depressed mood, agitation, changes in behavior, suicidal ideation, and suicide in patients attempting to quit smoking while taking CHANTIX. There is no scientific evidence establishing a causal relationship between CHANTIX and these reported events.

It is important to understand the nature of spontaneous post-marketing adverse event reporting. Often these reports lack sufficient medical information to enable meaningful assessment. They can come from any person or source ranging from consumers to health care providers, and from phone calls to internet postings.

In addition, smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. In the post-marketing reports, not all patients had known pre-existing psychiatric illness and not all had discontinued smoking.

In the controlled clinical trial program of more than 5000 patients treated with CHANTIX, adverse events related to changes in behavior or psychiatric symptoms, including suicidal ideation, were rare and occurred at a rate comparable to placebo-treated patients. There were no suicides in patients taking CHANTIX in our clinical trials.

Smoking is the leading preventable cause of disease and premature death in the United States, with more than 399,000 US deaths annually attributable to smoking. It causes a number of cancers, is a risk factor for cardiovascular disease, harms nearly every organ in the body, and diminishes health generally.

CHANTIX, a selective nicotinic acetylcholine receptor partial agonist, is the first non-nicotine prescription treatment for smoking cessation in almost a decade and is an effective treatment option for many patients who are trying to quit smoking.

Pfizer is vigilant in monitoring adverse drug reports for all of its products, and has extensive systems in place to collect, review and report these data.

For a complete listing of the adverse events associated with CHANTIX, please see the prescribing information at www.chantix.com.

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