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.
美國FDA表示，戒煙對健康的好處超過了伐尼克蘭中亞硝胺不純物帶來的癌症風險。
FDA 表示，加拿大仿製藥製造商 Apotex 將被暫時允許在美國配送 Apo-Varenicline 片劑，以幫助在短期內維持該國足夠的伐尼克蘭供應。
FDA 表示，亞硝胺不純物，稱為 N-亞硝基伐尼克蘭(N-nitroso-varenicline)，可能與人類潛在的癌症風險增加有關，但服用這種藥物的患者沒有立即風險。
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.
FDA 確定輝瑞召回的伐尼克蘭對患者構成不必要的風險，並建議醫療保健專業人員考慮其他可用的治療方案。
The FDA determined that varenicline recalled by Pfizer poses an unnecessary risk to patients and recommended healthcare professionals to consider other available treatment options.
The United States: FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level (English only)
