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Public Safety Advocates Want Stronger Warnings Printed on Chantix

Update Date: Oct 08, 2014 01:47 PM EDT

Five advocacy groups are calling for stronger warning labels to be printed on boxes of Chantix, an anti-smoking drug manufactured by one of the largest pharmaceutical companies, Pfizer, Inc. The public safety advocates have petitioned the United States Food and Drug Administration (FDA) this Wednesday to take action.

According to these advocates, they want Chantix boxes to include more warnings about the side effects of taking this drug. The current label lists mood changes, depression, hostility and suicidal behavior as potential side effects. It also warns patients on the drug to stop taking Chantix immediately if they experience these side effects. The groups want other side effects, such as risks of blackouts and convulsions, to be included on the label. The boxed warning label was first introduced in 2009.

The groups added that the FDA "substantially underestimated the psychiatric adverse effects and accident risks of Chantix," according to Medical Xpress.

Just last year, Pfizer settled around 2,500 lawsuits by agreeing to pay more than $275 million for side effects that included psychiatric problems, injuries and suicides. During the same year, the drug brought in $648 million in global sales.

Chantix works by binding to the spots in the brain that can be activated by nicotine. By binding to them first, the nicotine ends up having nothing to bind to. If nicotine cannot reach these spots, the "feel-good" chemicals will not be released, which makes smoking less pleasurable.

The recent call to change the labels comes right before the FDA is set to meet publicly in regards to the risks associated with taking Chantix. According to Pfizer's studies, there is no link between the drug and suicidal behavior. Pfizer executives have stated that they plan on asking for the removal of the boxed warning and will argue that the warning is unnecessary.

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