Drugs, Not a Safe Method to Quit Smoking
Anti-tobacco researchers explained that better is to quit smoking without drugs help. Because they recently found that drugs which are used to quit smoking are linked to an increase in mental side effects.
The mood changes are common and the FDA has informed producers 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, behavioral changes, suicidal thoughts or thoughts of dying.
The Food and Drug Administration on July 1st, 2009 said it will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.
The mental or mood disorders were determined through the use of the FDA’s Adverse Event Reporting System or AERS. 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 obey their own reports through MedWatch.
After receiving multiple reports offered 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.
