Heart of Health Policy | Additional ARBs Added to FDA Recall List Due to Contamination
In July of 2018, the U.S. Food and Drug Administration (FDA) announced a series of voluntary recalls for several lots of valsartan-containing products due to contamination with the possible carcinogen N-nitrosodimethylamine (NDMA).
The list of recalled products has continued to grow as more companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan, have discovered lots of drugs contaminated with NDMA or N-nitrosodiethylamine (NDEA).
Patients prescribed the affected products should not spontaneously discontinue treatment with these medications, as the risk of harm to the patients' health may be higher if the treatment is stopped immediately without any alternative treatment.
While the FDA's investigation is ongoing, the ACC is actively working to keep members up-to-date on the latest information. Click here for links to review updated lists of irbesartan products under recall, losartan medications under recall, valsartan products under recall and valsartan products not under recall.
Keywords: ACC Publications, Cardiology Magazine, Health Policy, Diethylnitrosamine, Angiotensin Receptor Antagonists, Losartan, Dimethylnitrosamine, United States Food and Drug Administration, Tetrazoles, Product Recalls and Withdrawals, Drug Recalls, Biphenyl Compounds, Pharmaceutical Preparations, Carcinogens
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