Trace Amounts of N-Nitrosodiethylamine (NDEA) Prompt Recall of Valsartan Drugs, Other Products

^{Note: This article was updated on 04.25.19} 

Mylan Pharmaceutical’s voluntary recall of its valsartan -containing blood pressure medications triggered an avalanche of recalls from other companies who produce valsartan drugs. 

According to the reports listed by the FDA, the recalls have been announced after traces of API impurities N-Nitrosodiethylamine (NDEA), a ‘probable’ human carcinogen, and N-Nitroso N-Methyl-4-amino butyric acid (NMBA), a ‘potential’ human carcinogen. 

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The EPA regards “probable human carcinogens” as agents with sufficient evidence from animal studies, but limited or nonexclusive human evidence, to be regarded as carcinogenic. ‘Potential’ or ‘possible human carcinogens’ are agents with limited animal evidence and little or no human data to support carcinogenic effects. 

Losartan and Valsartan recalls began in 2018 and have continued throughout the first part of 2019. Patients who are on Losartan should continue taking their medications despite the recall notices, as immediate cessation without a readily available alternative is a reportedly greater health risk than consuming either probable or possible carcinogen.

The following lists are compilations of recalls starting in December 2018. Hyperlinks provide comprehensive, specific lot recall information.

 

Complete, Updated List of Valsartan Products Under Recall

 

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