Pfizer has expanded its voluntary recall of smoking cessation drug varenicline (Chantix) to 12 lots at the consumer level, according to an update posted on the US Food and Drug Administration (FDA) website.
On July 2, the FDA alerted patients and healthcare professionals of Pfizer’s voluntary recall of nine lots of varenicline because of the possibility that the tablets may contain a nitrosamine impurity, N-nitroso-varenicline, at a level higher than the agency’s acceptable intake limit.
Pfizer has now added three more lots to the recall.
Table. Pfizer’s Recalled Lots to Date (*most recent additions)
| Lot number | Expiration date |
|---|---|
| 00020231 | Sept 2021 |
| 00020232 | Nov 2021 |
| 00020357 | Dec 2021 |
| 00020358 | Jan 2022 |
| 00020716 | Jan 2022 |
| 00019213 | Jan 2022 |
| ET1607 | Jan 2023 |
| ET1609 | Jan 2023 |
| EC6994 | May 2023 |
| *ET1600 | Jan 2023 |
| *EA6080 | Mar 2023 |
| *EC9843 | Mar 2023 |
In its latest update, the FDA once again states, “the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.”
“N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the FDA said, as reported earlier this week by Medscape Medical News.
The FDA also said earlier this week that it would not object to distribution of varenicline that contained levels of the nitrosamine impurity higher than its acceptable intake limit of 37 ng/d but lower than the interim acceptable intake limit of 185 ng/d until the impurity is eliminated or reduced to acceptable levels.
For now, the FDA is advising patients who are taking recalled varenicline to continue taking the medication until their pharmacist provides a replacement or their doctor prescribes a different smoking cessation medication.
The recalled varenicline lots were distributed in the United States and Puerto Rico from June 2019 to June 2021.
Pfizer says it has notified its direct clients by letter to arrange for the return of any recalled product.
The agency is also asking wholesalers and distributors with an existing inventory that includes the recalled lots to stop use and distribution, to quarantine the product, and to notify any accounts about the recall.
The FDA encourages healthcare professionals to report any adverse reactions with varenicline to the agency’s MedWatch program.
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