On Friday Pfizer announced that a labeling change for the popular stop smoking drug Chantix. The FDA is conducting an ongoing investigation of the drug and its possible link to suicidal thoughts and other psychological effects. The label has been altered to reflect the fact that some patients may experience “serious nueropsychiatric symptoms” including but not limited to suicidal behavior. Chantix was approved by the FDA in 2006 as a stop smoking aid and has seen tremendous success since its approval with continued growth in sales revenue combined with thousands of success stories. However, shortly following the September shooting death of musician Carter Albrecht, who was shot and killed after a series of bizarre psychotic events while taking Chantix, reports began to flood into the FDA’s Adverse Event Reporting System with claims of psychological side effects.
In November the FDA issued an early communication warning physicians and patients alike that the drug could be linked to suicidal thought and behavior. They encouraged doctors to closely monitor patients taking Chantix and report all side effects to the FDA. This new warning says that a possible link cannot be ruled out in some cases. This is not to say that a causal relationship has been established but this is a step in that direction.
The drug company said this latest update was to ensure doctors and patients can better weigh up the benefits versus the risks of the various ways to quit smoking and the treatments available, including Chantix.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.
Comments for this article are closed.