The list of valsartan-containing blood pressure and heart failure drugs recalled due to the presence of a cancer-causing substance has once again expanded to include all lots of Torrent Pharmaceuticals Limited valsartan/amlodipine/HCTZ, valsartan/amlodipine, and valsartan tablets, according to the Food and Drug Administration (FDA).
The recall was initiated on July 13 for certain valsartan tablets because they were found to contain a chemical known as N-nitrocodimethylamine (NDMA) in levels that exceeded those considered acceptable for public safety. The chemical is sometimes found in water supplies and food and is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen, meaning it can increase a person’s risk of developing cancer.
In the weeks since the recall was first initiated, the FDA has expanded the list of affected valsartan-containing products. The agency also said that the impurity may have been present in some drugs for as long as four years.
Valsartan-containing products affected by the recall include those manufactured by Teva Pharmaceuticals labeled as Major Pharmaceuticals; Prinston Pharmaceuticals Inc., labeled as Solco Healthcare LLC; Teva Pharmaceuticals USA labeled as Actavis; AvKARE; Remedy Repack; A-S Medication Solutions LLC; Bryant Ranch Prepack Inc.; H.J. Harkins Company Inc., doing business as Pharma Pac; Proficient Rx LP; Northwind Pharmaceuticals; Camber Pharmaceuticals Inc.; and NuCare Pharmaceuticals Inc. The latest update includes all lots of valsartan-containing drugs from Torrent Pharmaceuticals.
Valsartan is used to control high blood pressure and treat heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Before discontinuing valsartan, patients are advised to contact their pharmacist or physician about an alternative treatment as there can be risks to patients’ health if they immediately stop these medications without any alternative treatment.