Mylan Pharmaceuticals expanded its voluntary drug recall to include all unexpired valsartan-containing products in the U.S., the FDA announced Dec. 4. The action joins a host of other recalls over the last few months related to carcinogenic impurities being found in angiotensin II receptor blockers (ARBs), a class of medications used to treat hypertension and heart failure.
Mylan’s expanded recall includes 104 additional lots distributed in the U.S. between March 2017 and November 2018, including 26 lots of amlodipine/valsartan tablets, 51 lots of valsartan tablets and 27 lots of valsartan/hydrochlorothiazide tablets. The company initially recalled 15 lots of the medications in November.
The manufacturer said the recalls are due to trace amounts of N-nitrosodiethylamine (NDEA) being detected in the drugs. NDEA can occur naturally in industrial processes and is classified as a probable human carcinogen by the International Agency for Research on Cancer.
As with the previous ARB recalls, Mylan recommends patients continue taking valsartan products until an alternative is found, “as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.” Patients should contact their physician or pharmacist to discuss their options, and Mylan has sent letters to distributors notifying them of the recall.