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Food and Drug Administration petitioned to expand Chantix warning

Ohio residents who would like to stop smoking have probably tried a number of smoking-cessation products. There are several over-the-counter and prescription level treatments that have been proven to help, but the safety of one prescribed treatment in particular is facing scrutiny from safety advocates. The Food and Drug Administration has recently been petitioned by five different advocacy groups to expand warning labels on the anti-smoking drug Chantix.

Chantix was introduced to the market in 2006 by Pfizer. The drug is supposed to work by blocking nicotine from attaching to specific spots in the brain that activate the feel-good response, therefore minimizing the need to use products containing nicotine. Pfizer has made hundreds of millions of dollars every year since releasing this drug for consumer use. However, the company has also paid out approximately $300 million to settle over 2,500 lawsuits filed due to the negative side effects patients experienced by using this drug.

According to thousands of consumers, those using Chantix are at risk of experiencing suicidal behavior, depression, hostility and other psychiatric issues. Pfizer is actually in the process of trying to get these warning removed from the product, claiming extensive testing has not shown these issues to be relevant to the drug. Safety advocates, on the other hand, are saying the current warning label isn’t sufficient and that other potential side effects should be included on the label, including blackouts and convulsions.

At this time, it is unknown which way the Food and Drug Administration will go with this. Before a decision can be made, the FDA will hear from Pfizer, a group of experts and consumers. Ohio residents who have taken Chantix and have experienced any side effects beyond those listed on the warning label may file a legal complaint against Pfizer. Pharmaceutical liability claims can accomplish a few things, namely holding drug manufacturers responsible for product safety and allowing victims to obtain compensation for any financial losses suffered as a result of using these medications.

Source: thedenverchannel.com, “Safety advocates seek stronger warnings on Chantix”, Matthew Perrone, Oct. 8, 2014

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