McClain 1

Melinda McClain

Dr. Cassel

ENG 1201

27 March 2021

Medications Used for Smoking Cessation: How Safe and Effective Are They?

Tobacco use is the cause of 7 million deaths per year globally and costs the health

industry $300 billion a year to care for those who suffer from smoking related illness. Of the

34.2 million people in the United States that are current cigarette smokers, more than half have

attempted to quit in the past year with only 7.5% of them succeeding in their attempt to kick the

habit. (“Five New Ways to Quit With Medicine.”) Nicotine is one of the most addictive

substances on the planet and withdrawal from nicotine makes the process of quitting smoking

extremely difficult. There are prescription and over the counter medications that claim to help

smokers quit. How safe and effective are the medications used for smoking cessation?

Nicotine is quickly ingested by the body and is one of the most addictive substances on

the planet. Nicotine’s effect on dopamine in the brain and central nervous system reinforces

addiction and induces cravings. (Mishra, et al) Nicotine withdrawal and the cravings associated

with nicotine addictions are a stumbling block for many people who attempt to quit smoking.

Nicorette, a nicotine replacement treatment (NRT) hit the market in 1984 and in the years

since drug companies have developed two prescription medications, Zyban and Chantix, to

lessen the effects of nicotine withdrawal and assist smokers in kicking the habit. There has been

some controversy about the safety and effectiveness of NRT’s, Zyban, and Chantix when used

for smoking cessation. In 2009, after receiving reports that linked Zyban and Chantix to

psychiatric side effects that included suicidal thoughts, hostility and agitation, the FDA put a
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black lox warning on these drugs. In 2016, after 7 years of studies with mixed results, the FDA

removed the black box warning from Zyban and Chantix. As the public’s perception of smoking

shifts making smoking less socially acceptable and smoking bans become exceedingly restrictive

more smokers are choosing to quit but are leery of using these medications as an aid when

quitting smoking.

There is controversy about the physical health risk associated with medications used for

smoking cessation. Chantix combined with nicotine replacement therapy (NRT) is commonly

used as a smoking cessation treatment in the UK for patients who have a smoking related illness.

A case-crossover study was conducted by researchers at the University of Bristol and reported in

Mental Health Weekly Digest in 2020 found a positive association with nicotine replacement

therapy (NRT) and myocardial infarction. This crossover study reviewed medical information

from the UK-based electronic primary care records and looked for the final step that led to death

in patients that were prescribed Chantix and NRT therapy. There is a question of reliability with

the results of this study because these results may reflect health changes at the time that these

patients with cardiac problems were prescribed this treatment. The fact that smoking causes

many physical health problems, not just cardiac problems, would indicate that the use of NRT in

smoking cessation would be a safer health choice than continuing to smoke.

There is also controversy about the psychiatric risk associated with medications used for

smoking cessation. Some research indicates that the use of Zyban and Chantix may be

associated with feelings and self-harm while other research finds no connection between the use

of these medications and adverse psychological incidents. A research article written in 2016 by

members of the Faculty of Pharmaceutical Sciences at Josai University in Japan suggests the use

of Chantix alone is a latent risk factor inducing suicide. (Aklmoto, Hayato, et al.) This article
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detailed research on suicide-related events for different antidepressants when used for smoking

cessation treatment. This study was a statistical analysis of information obtained from the FDA

Adverse Event Reporting System that indicated when antidepressants were used for smoking

cessation there was a higher risk of suicide-related events with varenicline which carries the

trade name Chantix. This study was not a clinical trial performed with people in controlled

groups taking each medication or placebo, nor did it explore the psychiatric history of these

individuals. These issues were addressed in a clinical trial know as Evaluating Adverse Events

in a Global Smoking Cessation Study (EAGLES) which was a multinational trial that also took

place in 2016. This clinical trial was funded by Pfizer, the pharmaceutical company that markets

Chantix, and published in The Lancet. In this double-blind, randomized, placebo-controlled

clinical trial the safety and effectiveness of nicotine replacement therapy, Zyban, and Chantix

were studied in people with and without a history of psychiatric disorder. This clinical trial did

not show a significant increase in suicidal thoughts, hostility, or agitation attributable to Zyban or

Chantix relative to nicotine patch or placebo in people with or without a history of psychiatric

disorders. (Anthenelli, Robert M., et al)

Research indicates that medications used for smoking cessation are effective. A report

from researchers in Taiwan and published the Public Library of Science corroborated the

findings of the EAGLES study with regards to the effectiveness of NRT, Zyban, and Chantix.

This study found that at 6 months NRT had a 15.7% success rate, Zyban had a 16.2% success

rate, and Chantix had a 21.8% success rate when used for smoking cessation. (Chang, Po-Yin, et

al.) The success percentages are much higher for people who use medication while attempting to

kick the habit than people who quit smoking cold turkey.
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When combined with stop smoking treatments, smoking cessation medications become

even more effective. Cognitive behavioral therapy, motivational mobile applications and

Quitline-counseling increase the effectiveness of smoking cessation medication. Cognitive

behavioral therapy helps to retrain the brain to break harmful habits and negative thought

processes that coincide with addiction to nicotine. (Soltysiak 369-370) Motivational mobile

applications can help celebrate short-term goals and improve the attitude of individuals who are

attempting to quit smoking. Quitline-counseling helps to connect a person who has chosen to

quit smoking with the resources needed develop skills as well as a plan of short and long-term

goals to successfully quit smoking. The first long term study on the efficacy of medication for

use in smoking cessation, not funded by Pfizer, was a 2-year study published in 2020 and

combined the use of Chantix with Quitline-counselling as a randomized controlled clinical trial

for patients with smoking related illness. This clinical trial had the highest success rate with

Chantix plus Quitline-counselling as the most effective with a 29.2% success rate at the end of 2

years. (Carson-Chahhoud, Kristin V.) In this study the patients were selected from people who

were hospitalized with a tobacco related illness and the smoking cessation medication were

administer and monitored by medical staff which may explain this high success rate.

A common misconception with smoking cessation is that if a person wants to quit

smoking bad enough, they will be able to kick the habit cold turkey. While this statement may

be true for some ex-smokers, the statistics given each year on the number of people who

attempted to quit smoking and failed would indicate that is not the case for most people. Some

people who smoke may require medications to lessen the effects of nicotine addiction, and those

medications should be combined with motivational mobile applications and counseling to

increase the chances of success in quitting smoking.

Works Cited

Akimoto, Hayato, et al. "Assessment of the Risk of Suicide-Related Events Induced by Concomitant

Use of Antidepressants in Cases of Smoking Cessation Treatment with Varenicline and

Assessment of Latent Risk by the Use of Varenicline." PLoS ONE, vol. 11, no. 9, 2016, p.

e0163583. Gale In Context: Opposing

Viewpoints, link.gale.com/apps/doc/A471899239/OVIC?

u=dayt30401&sid=OVIC&xid=c5767159. Accessed 20 Mar. 2021.

Anthenelli, Robert M., et al. “Neuropsychiatric safety and efficacy of varenicline, bupropion, and

nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-

blind, randomized, placebo-controlled clinical trial.” Lancet, 22 April 2016, p. 2507.

http://dx.dol.org/10.1016/50140-6736(16)30272-0. Accessed 11 March 2021

Carson-Chahhoud, Kristin V., et al. "Two-year efficacy of varenicline tartrate and counselling

for inpatient smoking cessation (STOP study): A randomized controlled clinical

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u=dayt30401&sid=OVIC&xid=9e7e6cdb. Accessed 22 Feb. 2021.

Chang, Po-Yin, et al. "Comparative Effectiveness of Smoking Cessation Medications:

A National Prospective Cohort From Taiwan." PLoS ONE, vol. 11, no. 11, 2016, p.

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smoking/quit-smoking-medications/5-new-ways-to-quit-with-medicines/index.html.

Accessed 5 March 2021.

Mishra, et al. “Harmful effects of nicotine.” Indian journal of medical and paediatric

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