Certain lots of the therapy, distributed under the Actavis label in the US, have been detected to have trace amounts of probably human carcinogen NDMA.
Teva Pharmaceuticals USA has announced a voluntary recall of 80 lots containing its hypertension therapy valsartan (Diovan).
Certain lots of the therapy, distributed under the Actavis label in the US, have been detected to have trace amounts of probably human carcinogen N- nitrosodimethylamine (NDMA). The carcinogen was detected in an active pharmaceutical ingredient (API) manufactured by Zhejian Huahai Pharmaceutical.
The impurity NDMA is a substance that occurs naturally in foods, drinking water, air pollution, and industrial processes, according to the US Food and Drug Administration (FDA). It was classified as a probable carcinogen by the International Agency for Research on Cancer (IARC).
At the time of the announced recall, Teva had not received any reports of adverse events related to the recall of 29 single lots and 51 combinations lots of valsartan.
Valsartan is also used for the treatment of heart failure, and is indicated as a treatment for left ventricular failure, and dysfunction following myocardial infarction. It is commonly used in combination with hydrochlorothiazide to treat hypertension.
The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment. Patients currently on valsartan should continue taking their medication, however, as the risk of harm to the patient