Tobacco is associated with immediate and long-term adverse clinical outcomes, including morbidity and mortality. Although Pfizer’s Chantix (varenicline tartrate) showed prominent efficacy for dry eye disease treatment, its main utility has been in promoting smoking cessation. Put simply, varenicline is used for tobacco dependency treatment.
In July 2021, Pfizer paused Chantix production and recalled selected lots due to increased nitrosamine levels, and by September 2021, the company recalled all lots of Chantix. Consequently, very few effective treatments were available for nicotine and tobacco dependence.
The US Food and Drug Administration (FDA) allowed the distribution and use of the Canadian generic Apo-varenicline (varenicline tartrate) soon after the initial recall of Chantix. Later, the first FDA-approved generic varenicline became available.
Research Letter: Association of the Chantix Recall With US Prescribing of Varenicline and Other Medications for Nicotine Dependence. Image Credit: Africa Studio / Shutterstock
About the Study
The recent JAMA Network Open study evaluated how the Chantix recall influenced prescribing varenicline and other nicotine dependency medications. For this cross-sectional study, a large US-based national cohort was used. All relevant data between January 1, 2021, and June 30, 2022, was obtained from the national pharmacy benefit database.
This study included patients with commercial insurance, particularly those who received a prescription for nicotine dependence. Patients who were prescribed any forms of varenicline, such as generic, branded generic Apo-varenicline, and Chantix, sustained-release bupropion (150-mg tablets) and, nicotine replacement therapy (NRT), were included in the study.
Study Findings
Among 21,653,835 (2021) and 19,978,911 (2022) patients, 312,708 prescriptions for varenicline were filled by 238,258 patients. After Chantix production was halted, a significant reduction in the prescribed varenicline was observed. This finding implies that a significant decrease in the use of varenicline occurred after the removal of Chantix from the market. Subsequently, no significant change in the use of sustained-release bupropion or NRT was observed throughout the study period.
The current study has some limitations that include not accounting for patients with over-the-counter NRT purchases, and the study cohort was limited to those with commercial insurance.
Study Insights
The authors pointed out that in the US, the reduction in varenicline use was not due to a dearth in availability but due to accessibility. Two of the factors associated with the reduction in varenicline use are a lack of awareness among clinicians and patients regarding the availability of varenicline and concerns about nitrosamine.
A widespread advertisement campaign about generic varenicline availability could increase awareness among the concerned group. In addition, there is a need to address the myths associated with nitrosamines in varenicline products and highlight how usage of the drug outweighs the harm from cigarettes.
In the future, better medication recall procedures and communication are required to avoid the repetition of unnecessary decreases in varenicline use. This decrease could lead to a potential loss in nicotine cessation opportunities for smokers, which could have otherwise benefitted them immensely.
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