FDA seeks with­draw­al of heart­burn drugs due to new car­cino­gen con­cerns

The FDA on Wednes­day re­quest­ed that all man­u­fac­tur­ers of drugs con­tain­ing ran­i­ti­dine (com­mon­ly known as Zan­tac and used for heart­burn) re­move all pre­scrip­tion and over-the-counter (OTC) ver­sions from the mar­ket be­cause the car­cino­gen N-Ni­troso­di­methy­lamine (ND­MA) has now been found to in­crease sig­nif­i­cant­ly in sam­ples stored at high­er tem­per­a­tures.

The an­nounce­ment is the most se­ri­ous in a chain of FDA safe­ty ad­vi­sories re­lat­ed to ND­MA in ran­i­ti­dine med­i­cines fol­low­ing a se­ries of re­calls of Zan­tac and oth­er ran­i­ti­dine drugs, and as the agency said last No­vem­ber that the ND­MA lev­els in such drugs “are sim­i­lar to the lev­els you would ex­pect to be ex­posed to if you ate com­mon foods like grilled or smoked meats.”

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