Pfizer expands recall of anti-smoking drug over carcinogen presence

USA – Pfizer has said it is recalling four additional lots of its anti-smoking treatment, Chantix, after finding elevated levels of cancer-causing agents called nitrosamines in the pills.

In June, the drug maker said it was pausing distribution of certain lots of the anti-smoking drug out of an abundance of caution and pending further testing.

The Food and Drug Administration last year found high levels of NDMA in some versions of the popular diabetes drug metformin. NDMA contamination was responsible for the recall of heartburn drug Zantac sold by Sanofi in 2019.

Chantix was approved by the FDA in May 2006 as a prescription medication which helps adults aged 18 and over quit smoking and is used for 12 to 24 weeks.

Global revenue from Chantix fell 17% to US$919 million in 2020 as COVID-19 curbs hampered demand and the company lost patent protection in the United States in November.

The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said.

Including this recall, Pfizer has paused distribution of 16 lots of the drug. The lots were distributed to wholesalers in the United States and Puerto Rico from June 2019 to June 2021.

Pfizer said that so far it has not received any reports of adverse events related to this recall, but advised patients currently taking Chantix to consult with their doctor to confirm if they received an affected lot and seek alternative treatment options if appropriate.

Currently there are two main prescription medications that may be prescribed to help people quit smoking, Zyban and Chantix.

According to fortune business insights, the global nicotine replacement therapy market is expected to gain momentum by exhibiting a CAGR of 4.2% between 2020 and 2027.

This is attributable to increasing incidence of chronic disease such as lung cancer, strokes, and respiratory ailments. Additionally, introduction of innovative products by major companies will favor market growth.

Furthermore, the market was valued at US$2.55 billion in 2019 and is projected to reach US$3.54 billion by 2027.

Nicotine replacement therapy is a treatment that involves administering the smoking addicts with nicotine in the form of patches, inhalers, gums, sprays, and lozenges that does not contain harmful chemicals compared to tobacco.

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