Eustis, VA—The use of varenicline for smoking cessation declined after the recall of the brand-name drug Chantix nearly 2 years ago, and a new study warned that the “lost opportunities” likely had “immediate and long-term adverse health outcomes.”

Pfizer halted the production of Chantix (varenicline tartrate) in July 2021 and recalled select lots due to elevated nitrosamine levels, according to the report in Journal of the American Medical Association Network Open.The McDonald Army Health Center–led study pointed out that the recall “created a shortage of an effective treatment for tobacco and nicotine dependence.” While the FDA allowed the U.S. distribution of the Canadian generic Apo-varenicline (varenicline tartrate), all lots of Chantix were recalled by Pfizer that September.

“Shortly thereafter, the first FDA-approved generic varenicline became available,” according to the researchers. “Our objective was to evaluate the Chantix recall in terms of prescribing of varenicline and other medications for nicotine dependence in a large U.S. national patient cohort.”

The study team extracted data from a national pharmacy benefit database, which included 73.3% of patients with commercial insurance from January 1, 2021, to June 30, 2022. The focus was on commercially insured patients with a prescription for a medication to treat nicotine dependence.

The medications included were:

• Varenicline, including generic, branded-generic Apo-varenicline, and Chantix
• Nicotine replacement therapy (NRT; all forms)
• Sustained-release bupropion (150-mg tablets only).

Among about 2.7 million patients in 2021 and about 20 million in 2022, 312,708 prescriptions (30-day equivalent) for varenicline were filled by 238,258 patients. In August 2021, however, the month after the production halt of Chantix, the prevalence of patients prescribed varenicline decreased from 536 per one million in June to 146 per one million, the researchers reported.

By September 2021, the use of varenicline was 136 per one million, “which represented a 74.7% absolute reduction (P <.001) compared with the pre-washout period before increasing monthly thereafter,” according to the article. “There was a significant increase in varenicline use in the period starting October 2021; however, by June 2022, the use of varenicline was still lower than in June 2021.”

No significant change in the use of sustained-release bupropion or NRT throughout the study period was identified.

“In the U.S., the continuing dearth of varenicline claims through June 2022 was not due to a lack of drug availability but to accessibility,” the authors explained. “The lack of clinician and patient awareness regarding the availability of varenicline after the recall and concerns about nitrosamine were likely factors. The U.S. could benefit from FDA-initiated public service announcements to spread knowledge of the availability of generic varenicline and to counter myths that nitrosamines in varenicline products outweigh harms from cigarettes.”

The study recommended, “Policy changes to improve medication recall procedures and communication could help mitigate recurrence of an event at this magnitude. The substantial decrease in varenicline use after the Chantix recall represented potential lost opportunities for nicotine cessation with likely immediate and long-term adverse health outcomes.”

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