US FDA to Temporarily Allow Distribution of Anti-Smoking Pills Containing Impurities

July 16 (Reuters) – The U.S. drug regulator announced Friday that it will temporarily allow manufacturers to distribute versions of Pfizer Inc’s (PFE.N) anti-smoking drug Chantix that contain high levels of impurities that can cause cancer, in order to maintain supplies.

Drugmaker Pfizer halted distribution of Chantix, or varenicline, in June and recalled a number of lots after finding high levels of carcinogens called nitrosamines in the pills. (https://reut.rs/3Bd8SJh)

The Food and Drug Administration (FDA) will temporarily allow certain manufacturers to dispense varenicline containing impurities above its acceptable intake limit of 37 nanograms (ng) per day, but below an acceptable intake limit provisional of 185 ng per day, until the impurity can be removed or reduced to acceptable levels.

The regulator said the health benefits of quitting smoking outweighs the cancer risk from the nitrosamine impurity in varenicline.

Canadian generic drug maker Apotex will be temporarily cleared to distribute Apo-Varenicline tablets in the United States to help maintain an adequate supply of varenicline in the country in the short term, the FDA said.

The nitrosamine impurity, called N-nitroso-varenicline, may be associated with a potential increased risk of cancer in humans, but there is no immediate risk to patients taking this drug, the FDA said.

The risk of carcinogen exposure at intermediate acceptable intake levels of up to 185 ng per day presents minimal additional cancer risk, compared with lifetime exposure at the 37 ng per day level, the agency.

The FDA has determined that the recalled varenicline from Pfizer poses an unnecessary risk to patients and has recommended that healthcare professionals consider other available treatment options.

Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath

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