Nearly 90 Lots Of Losartan Recalled Over Carcinogen Presence

Nearly 90 Lots Of Losartan Recalled Over Carcinogen Presence

Introduction

The U.S. Food & Drug Administration (FDA) found a third type of carcinogen called N-Nitroso N-Methyl 4-aminobutyric acid (NMBA) in the popular blood pressure medicine Losartan and announced a recall on February 28, 2019.

Losartan belongs to the class of drug called angiotensin II receptor blockers (ARBs), which are used to treat high blood pressure and heart failure. The recall affected nearly 90 lots of Losartan potassium tablets manufactured by Hetero Labs in India and distributed by Camber Pharmaceuticals. This is the first time a hypertension medication was found to have NMBA. Similar recalls announced in 2018 were the result of N-Nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA) contamination. FDA Commissioner Scott Gottlieb, M.D. stated, "our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients.” An FDA analysis in recalled valsartan revealed that the overall risk to individual patients was very low. The agency warns, consumers are supposed to check the list of recalled valsartan products, losartan medications, and irbesartan products on the FDA's website, where data gets updated regularly. Patients must avoid stopping ARB medication until a replacement medicine has been offered to them, or else they might encounter life-threatening cardiac or blood pressure events.

The drugs affected due to the recall are packed in 30,90, 500, and 1000 count bottles with the following NCD number: Losartan 25 mg, Losartan 50 mg, and Losartan 100 mg.