A third medication for high blood pressure has been found to contain trace amounts of a suspected cancer-causing agent, prompting another recall. This time, Sandoz Inc., recalled one lot of losartan potassium hydrochlorothiazide tablets after trace amounts of the impurity N-nitrosodiethylamine (NDEA) was detected.
The active pharmaceutical ingredient losartan was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz’s losartan potassium hydrochlorothiazide is manufactured by Lek Pharmaceuticals dd, Ljubijana, Slovenia. NDEA is classified as a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer (IARC).
Losartan potassium hydrochlorothiazide tablets are used to treat hypertension. The drug may be used alone or in combination with other antihypertensive agents. The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. This product was distributed nationwide to distributors. The affected product was not distributed prior to Oct. 8, 2018.
Losartan belongs to a class of drugs called angiotensin receptor blockers, or ARBs. In recent months, several recalls were initiated for the ARB valsartan, after it was found to contain trace amounts of NDEA as well as another possible carcinogen. Earlier this month, the Food and Drug Administration (FDA) issued a recall on the ARB irbesartan made by ScieGen, because some lots were found to contain NDEA as well.
The FDA said patients should continue to take their medication as directed and to discuss any concerns with their doctor or pharmacist before changing medication. Some medications may have been contaminated with NDMA for as much as four years.
FDA Safety Communication