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 Pfizer in June halted distribution of Chantix and recalled a number
of lots after finding elevated levels of nitrosamines in the pills.
On Friday, it recalled 12 more lots.
The Food and Drug Administration (FDA) will temporarily allow some
manufacturers to distribute varenicline containing impurities above
its intake limit of 37 nanograms per day, but below an interim limit
of 185 ng per day, until the impurity can be eliminated or reduced
to acceptable levels.
The regulator said the health benefits of stopping smoking outweigh
the cancer risk from the nitrosamine impurity in varenicline.
Canadian generic drugmaker Apotex will be temporarily allowed to
distribute Apo-Varenicline tablets in the United States to help
maintain adequate varenicline supply in the country for the near
term, the FDA said.
The nitrosamine impurity, called 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.
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 Risk of exposure to the
carcinogen at interim acceptable intake levels
up to 185 ng per day presents minimal additional
cancer risk, compared with a lifetime exposure
at the 37 ng per day level, the agency said.
The FDA determined that varenicline recalled by
Pfizer poses an unnecessary risk to patients and
recommended healthcare professionals to consider
other available treatment options.
(Reporting by Trisha Roy and Additional
reporting by Sabahatjahan Contractor in
Bengaluru; Editing by Devika Syamnath and
Cynthia Osterman)
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