Angiotensin receptor blockers (ARBs) are commonly used to treat hypertension, heart failure and diabetic nephropathy. Following months of evaluation by the FDA, some ARB products were found to contain NMDA (N-Nitrosodimethylamine) and NDEA (N-Nitrosodiethylamine). These nitrosamines, which are probable human carcinogens, were identified in certain lots of generic valsartan, irbesartan and losartan – both single drug and combination products (eg, an ARB with amlodipine or hydrochlorothiazide). Failure to follow good manufacturing processes appears to be the cause.
Tell patients that very few ARB manufacturers and lots are included in the recall. Reassure them that the increased risk of developing cancer linked with taking the contaminated products is very low – about 0.01%. Patients should continue taking their ARB while determining wheather it has been recalled. Consult the FDA website at https://www.fda.gov/ drugs/drugsafety/ucm613916.htm for the manufacturers and lots affected. For patients taking recalled products, suggest a replacement ARB or another treatment option to prescribers.