Chantix (Varenicline) and Risk of Cardiovascular Events

Transcription

1 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER August 2011 Chantix (Varenicline) and Risk of Cardiovascular Events The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk. FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo (see Data Summary below). In this trial, Chantix was effective in helping patients quit smoking and remain abstinent from smoking for as long as one year. Cardiovascular adverse events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo. Health care professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease. Patients taking Chantix should contact their health care professional if they experience new or worsening symptoms of cardiovascular disease. FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebocontrolled trials. FDA will update the public when additional information is available. Additional Information for Patients Smoking is a major risk factor for cardiovascular disease, and Chantix can help you quit smoking. If you have cardiovascular disease, taking Chantix may increase your risk of certain cardiovascular adverse events. Contact your health care professional if you experience new or worsening symptoms of cardiovascular disease while taking Chantix, for example: 1. Shortness of breath or trouble breathing 2. New or worsening chest pain 3. New or worse pain in legs when walking Read the Medication Guide you get along with your Chantix prescription. It explains the risks associated with the use of Chantix. Talk to your health care professional if you have questions or concerns about Chantix. Additional Information for Health care Professionals Smoking is an independent and major risk factor for cardiovascular disease, and Chantix is effective in helping patients quit smoking. Be aware that a small, increased risk of certain cardiovascular adverse events was reported in a study of patients with cardiovascular disease receiving Chantix. The events included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease. Weigh the known benefits of Chantix against the potential risks of its use in smokers with cardiovascular disease. Counsel patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking Chantix. Encourage patients to read the Medication Guide they receive along with their Chantix prescription. Copyright 2011 by Therapeutic Research Center P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~ ~

2 (PL Detail-Document #270803: Page 2 of 3) Data Summary FDA reviewed a randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease (other than, or in addition to, hypertension) that had been diagnosed at least two months prior to the screening visit. Patients were randomized to treatment with Chantix 1 mg twice daily (n=350) or placebo (n=350). The study consisted of a 12- week treatment period that was followed by a 40- week non-treatment period. Patients also received smoking cessation counseling throughout the study. The 4-week Continuous Quit Rate (CQR) for weeks nine through 12 was obtained through weekly reports of cigarette or other nicotine use since the last study visit, and confirmed by measurement of end-expiratory exhaled carbon monoxide 10 ppm. The results showed a statistically significantly higher 4-week CQR in the Chantix arm compared with the placebo arm (47% versus 14%, respectively; p<0.0001). The continuous abstinence rate from week nine through week 52 of the study was also significantly higher in the Chantix group compared with the placebo group (19% versus 7%, respectively; p<0.0001). Certain cardiovascular adverse events were reported in more patients treated with Chantix than patients treated with placebo. These included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease, as is shown in the table below. These events were reviewed by an independent cardiovascular endpoint committee. Some of the patients requiring coronary revascularization underwent the procedure as part of management of nonfatal myocardial infarction and hospitalization for angina pectoris. The trial was not designed to have statistical power to detect differences between the arms on the safety endpoints. Adjudicated Cardiovascular Events During the 52-Week Study Period ( 1% in any group) Varenicline N=353* n (%) Placebo N=350 n (%) Nonfatal myocardial infarction 7 (2.0) 3 (0.9) Need for coronary revascularization 8 (2.3) 3 (0.9) Hospitalization for angina pectoris 8 (2.3) 8 (2.3) New diagnosis of peripheral vascular disease (PVD) or admission for a procedure for the treatment of PVD 5 (1.4) 3 (0.9) *Three patients in the varenicline arm did not meet the protocol-specified definition of stable cardiovascular disease but were included in the safety analysis population. Patients with need for coronary revascularization in the varenicline arm include 5 patients who are also counted under nonfatal myocardial infarction and/or hospitalization for angina pectoris events. Patients with need for coronary revascularization in the placebo arm include 2 patients who are also counted under nonfatal myocardial infarction and/or hospitalization for angina pectoris. Copyright 2011 by Therapeutic Research Center P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~ ~

3 (PL Detail-Document #270803: Page 3 of 3) [Report adverse events involving Chantix to the FDA MedWatch program at medwatch-online.htm.] The above excerpts are reprinted from the June 16, 2011, FDA safety communication concerning the possible increased risk of cardiovascular events with use of Chantix. Safety/ucm htm. Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication. Cite this document as follows: PL Detail-Document, Chantix (Varenicline) and Risk of Cardiovascular Events. Pharmacist s Letter/Prescriber s Letter. August Evidence and Recommendations You Can Trust 3120 West March Lane, P.O. Box 8190, Stockton, CA ~ TEL (209) ~ FAX (209) Copyright 2011 by Therapeutic Research Center Subscribers to the Letter can get PL Detail-Documents, like this one, on any topic covered in any issue by going to or

4 PL Detail-Document # This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER August 2011 Chantix (Varenicline): New Safety Information and Instructions For Use The U.S. Food and Drug Administration (FDA) has approved an updated drug label for the smoking cessation aid Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD). The updated label now also includes alternative directions for patients to select a quit smoking date. Updated information on the use of Chantix in patients with stable cardiovascular disease FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease. Patients received either Chantix 1 mg twice daily or placebo for 12 weeks and were followed for an additional 40 weeks. The clinical trial showed that Chantix was effective in helping patients with cardiovascular disease quit smoking, and more than doubled the chance that patients remain abstinent from smoking for as long as one year compared to patients treated with placebo. This information has now been added to the Chantix label. Because smoking is an independent and major risk factor for cardiovascular disease, smoking cessation is of particular importance in this patient population. This trial also demonstrated that Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in these patients FDA communicated about this potential risk and labeling update in the June 16, 2011 Drug Safety Communication. The absolute risk of cardiovascular adverse events with Chantix, in relation to its efficacy, is small. However, health care professionals should always weigh the potential benefits of Chantix against its potential risks when deciding to use the drug in patients with cardiovascular disease. Information on the use of Chantix in patients with COPD FDA reviewed a randomized clinical trial evaluating the efficacy and safety of Chantix in 460 patients at least 35 years of age who had mild-to-moderate COPD. Patients received either Chantix 1 mg twice daily or placebo for 12 weeks and were followed for an additional 40 weeks. The results showed that Chantix was more effective in helping COPD patients quit smoking and remain abstinent from smoking for as long as one year compared to placebo. Adverse events in this clinical trial were similar to those seen in studies that were conducted for Chantix s initial approval in 2006, and no new safety concerns were identified. Alternative directions for patients to select a quit smoking date after they have already started taking Chantix Previously, the Chantix drug label only included instructions for patients to first select a quit date, and then to start taking Chantix seven days before their quit date. FDA reviewed a randomized clinical trial in a general, otherwise healthy population of smokers who were instructed to begin taking Chantix, and then select a target quit date between Day 8 and Day 35 of treatment. Patients received either Chantix 1 mg twice daily or placebo for 12 weeks and were followed for an additional 12 weeks. The results showed that Chantix was more effective in helping patients quit smoking and remain abstinent from smoking for as long as 24 weeks compared to placebo. Adverse events in this clinical trial were similar to those seen in studies that were conducted for Chantix s initial approval in 2006, and no new safety concerns were identified. The updated label states that patients should start taking Chantix seven days before their quit date or alternatively, begin Chantix dosing and Copyright 2011 by Therapeutic Research Center P.O. Box 8190, Stockton, CA ~ Phone: ~ Fax: ~ ~

5 (PL Detail-Document #270803: Page 2 of 2) then quit smoking between Days 8 and 35 of treatment. Information from the three clinical trials has been added to the Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies, and Patient Counseling Information sections of the Chantix physician label. The patient Medication Guide has also been updated to include information about cardiovascular adverse events and alternative directions to select a quit date. Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication. The above excerpts are reprinted from the July 22, 2011 (updated July 25, 2011), FDA safety communication concerning changes to the Chantix product labeling. DrugSafety/ucm htm. Cite this document as follows: PL Detail-Document, Chantix (Varenicline): New Safety Information and Instructions For Use. Pharmacist s Letter/Prescriber s Letter. August Evidence and Recommendations You Can Trust 3120 West March Lane, P.O. Box 8190, Stockton, CA ~ TEL (209) ~ FAX (209) Copyright 2011 by Therapeutic Research Center Subscribers to the Letter can get PL Detail-Documents, like this one, on any topic covered in any issue by going to or

6 This Professional Resource gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER July 2016 ~ Resource # Smoking Cessation Drug Therapy Abbreviations: d = day; BID = twice daily; FAA = Federal Aviation Administration; MAOI = monoamine oxidase inhibitors; MI = myocardial infarction; NRT = Nicotine Replacement Therapy; OTC = Over-the-counter; Rx = prescription Please note: Information in chart may differ from product labeling. Doses are for healthy, adult patients. Doses for special populations (e.g., cardiovascular disease, low weight, etc) are not provided. Canadian dosing that differs significantly from U.S. information is noted. Some prescribers will determine a patient s level of nicotine dependence using a scale such as the Fagerstrom Test for Cigarette Dependence. This can help predict success at smoking cessation and guide the choice of therapy. 4 Drug Mechanism of Nicotine gum (Nicorette gum, etc) Nicotine replacement. Short-acting; Recent MI (within 2 weeks) 1 Serious Dyspepsia 12 Mouth irritation 15 Hiccups 12 2 to 4 mg (start with 4 mg for patients who smoke more than a pack [25 cigarettes] per day For increased efficacy, use for at least a allows flexible arrhythmias 1 Nausea 12 [Canada] or who smoke their first full 12 weeks. 12 dosing. 5 Serious or Jaw ache 5 cigarette within 30 min of waking Available OTC worsening angina [U.S]). 3,12 Use for up to Delays weight pectoris 1 6 months. 3,5,a gain. 1 Pregnancy 12 May stick to Coronary artery dentures or dental disease (history of work. 5 MI and/or angina pectoris) 14 Vasospastic disease (e.g., Prinzmetal s variant angina, Raynaud s phenomena, etc) 14 U.S.: 12 Weeks 1 to 6: every 1 to 2 hours (at least 9 pieces per day) Weeks 7 to 9: every 2 to 4 hours Weeks 10 to 12: every 4 to 8 hours Canada: 3 First 2 weeks:10 to 20 pieces per day Next 2 weeks: 8 to 15 pieces per day Month 2: 4 to 10 pieces per day Month 3: 2 to 5 pieces per day Month 4 to 6: 1 piece as needed Continued Continued

7 (Professional Resource #320751: Page 2 of 8) Drug Nicotine gum (Nicorette gum, etc), continued Mechanism of Max daily dose 24 pieces (20 pieces [Canada]). 3,12 Chew and park gum intermittently for about 30 minutes, until taste disappears. 3,12 No food or drink for 15 minutes before or while chewing. 5 Nicotine lozenge (Nicorette, generics) Continued Nicotine replacement. Short-acting; allows flexible dosing. 2 Available OTC Delays weight gain. 1 Nausea 5 Same as nicotine U.S.: 5 gum 1 Sore mouth/throat 15 2 to 4 mg (start with 4 mg for patients who smoke their first Hiccups 5 cigarette within 30 min of waking). 1 Heartburn 5 First 6 weeks: 1 lozenge every 1 to Trouble sleeping 5 2 hours (9 to 20 lozenges per day). Headache 5 Next 3 weeks: 1 lozenge every 2 to Coughing 5 4 hours. Next 3 weeks: 1 lozenge every 4 to 8 hours. Canada: 3 2 to 4 mg (start with 4 mg for patients who smoke more than a pack of cigarettes per day). 3 Weeks 1 to 6: 8 to 15 lozenges per day. Weeks 7 to 9: 4 to 8 lozenges per day. Weeks 10 to 12: 2 to 4 lozenges per day. Next 3 months: 1 to 2 lozenges per day if the urge to smoke returns. 3 months 5 (Canada: can continue to use as needed for up to 6 months). 3,a

8 (Professional Resource #320751: Page 3 of 8) Drug Mechanism of Nicotine lozenge (Nicorette, generics), continued Nicotine inhaler (Nicotrol [U.S.], Nicorette [Canada]) Nicotine replacement. Short-acting; allows for flexible dosing. 2 Rx only in U.S. OTC in Canada. Hand-to-mouth use mimics smoking action; provides a way to keep hand busy and cope with smoking cues. 3,5 Delays weight gain. 1 Same as nicotine gum 1 Caution in severe reactive airway disease 10 Local irritation of mouth and throat 10,15 Coughing 5,10 Rhinitis 10 Dyspepsia 5,10 Max: 5 lozenges in 6 hours, up to 20 per day. 5 Allow to dissolve in mouth (takes about 10 to 20 minutes); do not chew. 3,5 No food or drink for 15 minutes before or during use. 5 U.S.: 10,15 First 12 weeks: 6 to 16 cartridges per day. Next 6 to 12 weeks: taper as needed. Canada: 3 First 12 weeks: 6 to 12 cartridges per day. Weeks 12 to 24: taper gradually, stopping when at 1 to 2 cartridges per day. Each cartridge lasts about 20 minutes with frequent puffing. 3,10 Up to 6 months. 1,10,a Nicotine nasal spray (Nicotrol NS) U.S. only Continued Nicotine replacement. Short-acting; allows flexible dosing. 2 Rx only Fastest NRT delivery system. 5 Same as nicotine gum 1 Avoid in severe reactive airway disease 14 Nasal irritation and congestion 14,15 Sneezing 15 Changes in taste or smell 14 1 to 2 doses per hour 15 (1 dose = 1 spray in each nostril). 14 Do not exceed 10 sprays per hour or 80 sprays per day (i.e., 40 doses). 14,15 Aim for a minimum of 8 doses per day for best efficacy to 6 months. 1,5,14,a

9 (Professional Resource #320751: Page 4 of 8) Drug Nicotine nasal spray (Nicotrol NS), continued Mechanism of Rapidly relieves withdrawal symptoms. 5 Highest dependence potential among NRTs. 5 Delays weight gain. 1 Not recommended with chronic nasal disorders (e.g., rhinitis, nasal polyps, or sinusitis) 14 Side effects usually improve after 1 week of regular use 5,14 To minimize side effects, do not sniff, swallow, or inhale through nose during administration. 14 Tilt head back slightly during administration. 14 Encourage patients to stop smoking completely to decrease risk of adverse effects. 14 Nicotine patch (NicoDerm CQ, NicoDerm [Canada], Habitrol, generics) Nicotine replacement. Long-acting (continuousrelease) formulation. 16 Available OTC. Worn for 24 hours (if patient craves cigarettes on awakening), or for 16 hours to avoid insomnia. 16 Delays weight gain. 1 Same as nicotine Local skin gum 1 reactions 16 Insomnia and vivid dreams; lessen after 3 to 4 days 5,16 Individualize dose based on degree of dependence, number of cigarettes smoked per day, previous experience with patch, etc. 1 Smokes 10 cigarettes or less per day (Canada: or <45 kg, or heart disease with approval for use by prescriber): 16,17 First 6 weeks: 14 mg patch Weeks 7 and 8: 7 mg patch Weeks 9 and 10, if urge to smoke continues: 7 mg patch 17 Smokes more than 10 cigarettes per day: 16,17 First 6 weeks: 21 mg patch Weeks 7 and 8: 14 mg patch Weeks 9 and 10: 7 mg patch 8 to 12 weeks. 1,a FDA approved for 3 to 5 months. 5

10 (Professional Resource #320751: Page 5 of 8) Drug Nicotine oral mist (Nicorette) Canada only Mechanism of Nicotine replacement. Short-acting; allows flexible dosing. 2 Available OTC. Same as nicotine gum Hiccups 3 Tingling lips 3 Strong taste of nicotine 3 Weeks 1 to 6: 1 to 2 spays every half 12 weeks. 3 hour. 3 Weeks 7 to 9: decrease average number of sprays by half. 3 Weeks 10 to 12: 2 to 4 sprays per day. 3 Maximum: 2 sprays per dose, 4 sprays per hour, 64 sprays per day 3 Do not inhale. Avoid lips and spray directly into mouth. 3 Varenicline (Chantix) (Champix [Canada]) Blocks nicotine binding to alpha-4- Psychiatric disorders 5,7 Nausea 5 Vomiting 5 beta-2 nicotinic acetylcholine Cardiovascular disease 7 Insomnia/vivid dreams 5 receptors and at the Driving or Headache 5 same time partially operating Depressed mood, stimulates the machinery. 7 agitation, changes nicotinic receptor Seizures 7 in behavior, to reduce cravings U.S. FAA has suicidal ideation, (lessen pleasure) banned use in pilots and suicide 5 and withdrawal and air traffic symptoms. 2,5,7 controllers 9 Severe renal impairment (requires dose reduction) 7 Pregnancy 7 Start 1 week (Canada: 1 to 2 weeks) before quit date, 5 or patient can quit between days 8 and 35 of treatment. 7,8 Days 1 to 3: 0.5 mg once daily. 7,8 Days 4 to 7: 0.5 mg BID 7,8 (Canada: some may stay on this dose for duration). 8 Day 8 to Week 12: 1 mg BID 5,7,8 Use lower dose if adverse effects are intolerable. 5,7 Take after meals with a full glass of water. 5 Canada: consider tapering to decrease risk of smoking-cessation relapse and withdrawal symptoms to 24 weeks. 7,8 If smoking stopped during the first 12 weeks, can continue 12 weeks longer to increase efficacy. 5,7,8

11 (Professional Resource #320751: Page 6 of 8) Drug Sustainedrelease bupropion (Zyban, etc) Mechanism of Blocks re-uptake of dopamine and norepinephrine. Weak nicotinic receptor antagonist. 2 May be used with NRT. 5,6,13 Consider for smokers with history of depression. 2 Delays weight gain. 6 Contraindications: history of seizure, eating disorder, use of MAOI within the previous 14 days 5,13 Bipolar disorder 5,6,13 Heavy alcohol use 5 Serious head injury 5 Pregnancy 6,13 Renal impairment 13 Hepatic impairment 13 Insomnia 5,6,13 (if problematic, take second dose in afternoon, at least 8 hours after the first) 1,6 Dry mouth 5,6,13 Agitation 5,6 Irritability 5,6 Indigestion 5,6 Headaches mg once daily for 3 days, then 150 mg BID. 6,13 Start 1 to 2 weeks before quit date. 5,6,13 Max 150 mg per dose, 300 mg per day, and at least 8 hours between doses. 6,13 Moderate to severe hepatic impairment: 150 mg every other day to 12 weeks, 6,13 but prescriber may continue longer to prevent relapse to smoking 5,13 (Canada: up to 1 year). 6 Nortriptyline Noradrenergic effects may replace those of nicotine. 18 Second-line agent. 18 Conflicting efficacy results. 18 Driving or operating machinery 5 Avoid with cardiovascular disease, arrhythmia risk 5 Avoid with MAOIs 18 Pregnancy 2 Lethal in overdose 2 Sedation 5 Dry mouth 5 Constipation 5 Blurred vision 1 Tachycardia 5 Urinary retention 5 Lightheadedness 5 Impaired ability to drive or operate machinery 5 Start 10 to 28 days before quit date. 5,18 Initial dose 25 mg once daily. 2 Slowly increase to 75 to 100 mg once daily. 18 Taper when discontinuing weeks. 18 Consider continuing for up to 6 months. 1

12 (Professional Resource #320751: Page 7 of 8) Drug Clonidine, oral and transdermal patch (Catapres, etc) (Catapres-TTS patch, etc [U.S. only]) Mechanism of Stimulates alpha-2- Sedation 18 Dry mouth 5 Start 3 days before quit date. 5 4 to 11 adrenoceptors, Postural Drowsiness 5 Tablet: 0.1 mg BID, increasing by weeks. 18 reducing hypotension 18 Dizziness mg per day each week, if needed sympathetic Rebound Sedation 5 and tolerated, to a total daily dose of outflow. 18 hypertension 2 Constipation mg to 0.75 mg. 1,18 Reduces craving, Pregnancy 2 Patch: 0.1 mg/day patch applied restlessness, and Driving or once every 7 days, increasing to anxiety. 18 operating 0.2 mg/day patch after 1 week. 1 Second-line machinery 5 agent. 18 To discontinue, must be tapered over 2 to 4 days to avoid rebound hypertension. 5 a. NRT products can be used in combination, and in patients who continue smoking. Use of NRT products for longer than the duration indicated in the product labeling is safe in most cases. 11 Users of this resource are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication.

13 (Professional Resource #320751: Page 8 of 8) Project Leader in preparation of this professional resource: Annette Murray, BScPharm References 1. Fiore MC, Jaen CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Clinical practice guideline. U.S. Department of Health and Human Services. May (Accessed June 17, 2016). 2. Nides M. Update on pharmacologic options for smoking cessation treatment. Am J Med 2008;121:S McNeil Consumer Healthcare. Nicorette. (Accessed June 15, 2016). 4. World Health Organization, International Agency for Research on Cancer. Handbook of Cancer Prevention Volume 12: Methods for Evaluating Tobacco Control Policies Measurement of nicotine dependence (Chapter 3; pgs ). (Accessed June 17, 2016). 5. American Cancer Society. Guide to Quitting Smoking (nicotine replacement therapy; prescription drugs to help you quit smoking). guidetoquittingsmoking/index?sitearea. (Accessed October 7, 2016). 6. Product monograph for Zyban. Valeant Canada LP. Laval, QC H7L 4A8. March Product information for Chantix. Pfizer Inc. New York, NY June Product monograph for Champix. Pfizer Canada. Kirkland, QC H9J 2M5. December Federal Aviation Administration. Anti-smoking medicine Chantix banned. May 27, (Accessed June 17, 2016). 10. Product information for Nicotrol. Pharmacia and Upjohn Company. New York, NY June FDA. Nicotine Replacement Therapy Labels May Change. April s/ucm htm. (Accessed June 17, 2016). 12. Product information for Nicorette gum. GlaxoSmithKline Consumer Healthcare LP. Moon Township, PA November Product information for Zyban. GlaxoSmithKline. Research Triangle Park, NC June Product information for Nicotrol NS. Pharmacia and Upjohn Company. New York, NY May Klein JW. Pharmacotherapy for substance use disorders. Med Clin North Am 2016;100: Product information for Nicoderm CQ. GlaxoSmithKline Consumer Healthcare Holding (US) LLC. Moon Township, PA May Johnson & Johnson Inc. Nicoderm. February (Accessed June 16, 2016). 18. Barboza JL, Patel R, Patel P, Hudmon KS. An update on the pharmacotherapeutic interventions for smoking cessation. Expert Opin Pharmacother 2016;17: Cite this document as follows: Professional Resource, Smoking Cessation Drug Therapy. Pharmacist s Letter/Prescriber s Letter. July Evidence and Recommendations You Can Trust 3120 West March Lane, Stockton, CA ~ TEL (209) ~ FAX (209) Copyright 2016 by Therapeutic Research Center Subscribers to the Letter can get professional resources, like this one, on any topic covered in any issue by going to PharmacistsLetter.com, PrescribersLetter.com, PharmacyTechniciansLetter.com, or NursesLetter.com