FDA sup­ports lim­it­ed dis­tri­b­u­tion of an­ti­smok­ing drug Chan­tix de­spite car­cino­gen risk

Ear­li­er this month, the FDA alert­ed the pub­lic that Pfiz­er had vol­un­tar­i­ly re­called its stop-smok­ing drug Chan­tix af­ter find­ing el­e­vat­ed lev­els of can­cer-caus­ing ni­trosamines. Now, the FDA is per­mit­ting cer­tain man­u­fac­tur­ers to tem­porar­i­ly dis­trib­ute the drug that has more than the usu­al ni­trosamine, so long as it re­mains un­der the in­ter­im ac­cept­able lim­it.

Pfiz­er pre­vi­ous­ly halt­ed dis­tri­b­u­tion of Chan­tix and pulled four lots of the drug af­ter find­ing un­ac­cept­ably high lev­els of the ni­trosamine N-ni­troso-vareni­cline in rou­tine test­ing. In guid­ance re­leased Fri­day, the FDA set an in­ter­im al­low­able lim­it for that com­pound in Chan­tix at 185 ng per mil­li­liter to help en­sure ad­e­quate sup­ply of the drug in the US.

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