Black box warnings or (black label warnings) are a form of warning used by the U.S. Food and Drug Administration to warn consumers of a product that may have adverse effects which are serious or life-threatening. If medical studies show that the side effects of a drug may cause serious injury to the consumer, the FDA may require pharmaceutical companies to include a black box label warning of these dangers.
Black box warnings are considered the strongest warning issued by the FDA, and companies required to include the warnings or labels should comply with the letter of the law. Consumers should be wary of products bearing a black box warning and should consult a medical professional about the risks involved in taking the product.
Recently the FDA issued a black box warning for the smoking-cessation drug Chantix, after consumers reported serious side effects including suicidal thoughts, aggression, and depressive behavior. If you or someone you know has suffered injury caused by Chantix, contact the Chantix lawyers of the firm today.
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