Anti Smoking Drugs Linked to Increase in Mental Side Effects

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.

Popular Stop-Smoking Drugs Needs To Indicating Mental Health Risk Warnings

The U.S. Food and Drug Administration said it will immediately require boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of two popular smoking cessation drugs — varenicline (Chantix) and buproprion (Zyban, Wellbutrin and generics).

U.S. Food and Drug Administration

Reports of behavioral changes, depressed mood, agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA’s adverse event reporting system.

Throughout the marketing history of the drugs, there have been 98 suicides and 188 attempted suicides in varenicline users and 14 suicides and 17 attempted suicides in buproprion users, the agency reported.