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Voluntary Recall of Smoking Cessation Drug Chantix

For the last 15 years, adults have been able to use Chantix to try to quit smoking. The prescription medication manufactured by Pfizer is taken for no more than 24 weeks and works by interfering with receptors in the brain blocking the “pleasurable’’ effects of nicotine. As the person’s interest in smoking decreases, over time, the symptoms of nicotine withdrawal decrease too.

However, smokers who plan to use Chantix to battle their nicotine addiction should now seek an alternative. Although there is no immediate risk to those currently using the medication, Pfizer recently announced a recall on Chantix (varenicline). The recall is due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. According to the FDA, some nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.

Chantix is a smoking cessation medicine. Here it is display with a tobacco cigarette in an ashtray.

The issue surrounding nitrosamines (N-nitroso-varenicline) with Chantix first arose over the summer when Pfizer paused its distribution. In July, the manufacturer recalled 12 lots of the drug. This was followed up in August when the manufacturer pulled another four additional batches from distribution. 

Finally, on Sept. 16, Pfizer announced it voluntarily recalled all lots of Chantix (0.5 mg and 1 mg tablets) distributed from May 2019 to September 2021. 

The manufacturer described the actions as precautionary in the Chantix recall announcement posted on the Food and Drug Administration (FDA) website.  

“Chantix has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program,” the company statement read. “Pfizer believes the benefit/risk profile of Chantix remains positive…People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.”

The recall notice was followed by an update from the FDA on Sept. 17, encouraging patients to continue taking the recalled medicine until their pharmacist or doctor could provide a replacement. “The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline,” it stated. 

Past Problems with Chantix

Although Pfizer’s Chantix has been applauded over the years for helping thousands of people stop smoking, it has also been linked to causing mental health issues. 

In 2007, after the drug had already been prescribed four million times, Chantix was attributed to the death of Carter Albrecht, a well-known Texas musician. While Albrecht was taking Chantix, he began experiencing hallucinations which led to an unexpected altercation with a neighbor who accidentally shot him on his doorstep. After the shooting, Albrecht’s girlfriend shared that she and Albrecht had been trying to quit smoking together. In the days leading up to the shooting, they both were experiencing Chantix side effects, including frightening dreams.

Albrecht’s death, along with reported incidents from other users of Chantix, led to backlash from both consumers and mental health professionals against the Pfizer drug resulting in the FDA issuing a black box warning for Chantix in 2009. The agency’s most stringent warning alerted consumers of a potential link between Chantix and suicide, depression, and hostile behavior.

However, the black box warning stayed in place for less than eight years. In 2016, the FDA reviewed the results of an 8,000 person study that found the psychiatric side effects of smoker-participants taking Chantix were not significantly higher than those using a nicotine patch or those taking a placebo. Because of the study results and with the urging of officials at Pfizer, the FDA determined the black box warning could be removed while in its place was wording advising doctors and patients to watch for psychiatric side effects. 

At the end of 2020, Chantix sales totaled $919 million.

What Should You Do If You Are Taking Chantix?

While it is important to recognize that the distribution of Chantix has stopped, it is also important to continue recognizing the dangers of smoking cigarettes. According to the Centers for Disease Control (CDC), more than 16 million Americans live with a disease caused by smoking. Worldwide, tobacco use causes more than seven million deaths per year.

The FDA encourages Chantix users to continue taking their current prescription while consulting with their healthcare provider about alternative treatment options as soon as possible.