The warning acknowledges that nicotine withdrawal related to smoking cessation may contribute to these neuropsychiatric events. The warning also acknowledges that causality between the medication exposure and these events cannot be conclusively established and states that the risks of these medications should be weighed against the potential health benefits of quitting smoking.
It is recommended that clinicians closely monitor all patients taking varenicline and bupropion HCl. The premarketing smoking cessation studies of these medications excluded patients with serious psychiatric illness (e.g., schizophrenia, bipolar disorder, and major depressive disorder), suggesting that the safety of these medications for these patients has not been investigated.[7,9] Therefore, during smoking cessation, it is important to especially monitor patients with preexisting psychiatric illness who are receiving varenicline and bupropion HCl for smoking cessation.
Patients can be carefully matched to specific smoking cessation strategies. Some smokers can quit with the help of counseling or psychological interventions, while others might need nicotine replacement therapies. Some smokers might need medications to successfully quit smoking. Given the significant health benefits derived from smoking cessation, medications can be used in these patients with careful monitoring.
Table 6. Bupropion HCl
HCl = hydrochloride; Rx = prescription.
|�||Brand||Dose ||Side Effects||Warning/Precaution |
|Rx|| Zyban||150 mg/d � 3 days, then increase to 300 mg/d � 7-12 weeks||Insomnia, dry mouth, dizziness, rhinitis|| Do not take with Wellbutrin or Wellbutrin SR.|
|Higher incidence of seizures in patients treated for bulimia or anorexia.|
|Do not prescribe >300 mg/d for patients being treated for bulimia.|
Although bupropion HCl (Zyban) is the only FDA-approved antidepressant for smoking cessation, fluoxetine HCl (Prozac) has been studied and shown to be effective.[Level of evidence: I] However, fluoxetine HCl also carries a boxed warning describing an increased risk of suicidality in adults younger than 25 years. (Refer to the Depression and Suicide section in the PDQ summary on Pediatric Supportive Care for more information.)
Table 7. Fluoxetine HCl
HCl = hydrochloride; Rx = prescription.
|�||Brand|| Dose ||Side Effects|| Comments|
|Rx||Prozac ||30-60 mg/d || Insomnia, dizziness, anorexia, sexual dysfunction, confusion|| Limited data available on use in combination with cognitive-behavioral therapy.|
Lobeline (Bantron) is classified as a category III agent by the FDA (safe but no proven effectiveness). This product is not recommended for use in any smoking cessation program because of its lack of efficacy.
- Continued smoking substantially increases the likelihood of recurrence or occurrence of a second cancer in survivors, particularly in those who received radiation therapy.
- Most patients with smoking-related cancer appear motivated to quit smoking at the time of diagnosis.
- A stepped-care approach is recommended, with strong physician advice and brief counseling to quit and provision of basic information to all patients at each contact during the first month of diagnosis, followed by more intensive treatment (pharmacologic and counseling by a smoking specialist) for those having difficulty quitting or remaining abstinent.
- Fincham JE: Smoking cessation products. In: Covington TR, Berardi RR, Young LL, et al., eds.: Handbook of Nonprescription Drugs. 11th ed. Washington, DC: American Pharmaceutical Association, 1996, pp 715-723.
- Tonstad S, T�nnesen P, Hajek P, et al.: Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA 296 (1): 64-71, 2006.
- Nides M, Glover ED, Reus VI, et al.: Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. Am J Health Behav 32 (6): 664-75, 2008 Nov-Dec.
- U.S. Food and Drug Administration.: FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease. Silver Spring, Md: U.S. Food and Drug Administration, 2011. Available online. Last accessed August 22, 2011.
- Hitsman B, Pingitore R, Spring B, et al.: Antidepressant pharmacotherapy helps some cigarette smokers more than others. J Consult Clin Psychol 67 (4): 547-54, 1999.
- Hurt RD, Krook JE, Croghan IT, et al.: Nicotine patch therapy based on smoking rate followed by bupropion for prevention of relapse to smoking. J Clin Oncol 21 (5): 914-20, 2003.
- CHANTIX (varenicline) Tablets. New York, NY: Pfizer Inc., 2011. Available online. Last accessed August 22, 2011.
- Hughes JR: Smoking and suicide: a brief overview. Drug Alcohol Depend 98 (3): 169-78, 2008.
- U.S. Food and Drug Administration.: Information for Healthcare Professionals: Varenicline (Marketed as Chantix) and Bupropion (Marketed as Zyban, Wellbutrin, and Generics). Rockville, Md: U.S. Food and Drug Administration, 2009. Available online. Last accessed August 22, 2011.
- U.S. Food and Drug Administration.: Antidepressant Use in Children, Adolescents, and Adults. Rockville, Md: Food and Drug Administration, Center for Drug Evaluation and Research, 2007. Available online. Last accessed August 22, 2011.
- Drug Facts and Comparisons. St. Louis, Mo: Facts and Comparisons, 1998.