Anti smoking drugs linked to increase in mental side effects

July 3, 7:36 AMUS Headlines ExaminerCharisse Van Horn

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Two prescription drugs  that are used to quit smoking have been linked to an increase in mental side effects. The mood changes are prevalent and the FDA has instructed manufacturers of both Chantix (Varenicline) and Zyban (Bupropion) to place boxed warning labels on the packaging inserts and prescription drug information. Some of the changes in mood or mental side effects experienced include:

Depression
Anger or Hostility
Behavioral Changes
Suicidal Thoughts or thoughts of dying

The mental or mood disorders were determined through the use of the FDA’s Adverse Event Reporting System or AERS. Both consumers and health care professionals can use AERS to submit reports of adverse reactions to medications to the FDA. The tool helps identify reactions that were not identified during clinical trials or studies, but might have been identified after a medication has been approved for general use. Consumers can fill out forms for the AERS program with their health care provider, or they can submit their own reports through MedWatch.

After receiving multiple reports submitted by consumers and health care providers, the FDA has determined that the warning must be placed on both Chantix and Zyban. Zyban, or Bupropion, is also marketed as the anti-depressant drug, Wellbutrin. Patients using Wellbutrin have also experienced similar mood changes and found their mental disorders increased. Wellbutrin will also receive the boxed warning label. Generic versions of the drug will also receive the box warnings.

The new warnings will be in ‘boxed’ form. This means that the paper inserts that accompany the medication will have a black box with the warning information listed. Those using Chantix or Zyban should report any changes in mood or their mental well-being to their health care provider immediately.

In addition to the box warning, manufacturers of smoking cessation products will need to conduct clinical trials to determine how frequently the mental disorders, or neuropsychiatric symptoms occur. They will also need to determine whether the symptoms are more prone to occurring in patients with a previous history of mental disorders. Pfizer Inc manufacturers Chantix and GlaxoSmithKilne manufacturers Zyban.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking. Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research.

Reports gathered from AERS showed that many people who experienced mental side effects or mood disorders developed the symptoms after they started using the drugs. Their symptoms subsided upon cessation of the medications. There were, however, instances where the symptoms continued beyond cessation of the drugs, as well as those whose symptoms developed after they began and stopped using the medications. The FDA will require that manufacturers change their dosing recommendations as well as revise the drug’s medical information to include the psychiatric side effects.

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