Yet another blood pressure medication has been added to the list of recalled hypertension drugs.
The affected pills include valsartan, amlodipine/valsartan and valsartan/hydrochlorothiazide tablets and were distributed in the United States between March 2017 and November 2018. The FDA has listed additional information about the specifics, including doses, lot numbers and expiration dates, on its site.
According to the press release, the drugs contain traces of N-nitroso-diethylamine (NDEA). The impurity, typically found in certain foods, drinking water and air pollution, has been classified as a human carcinogen by the International Agency for Research on Cancer.
Mylan is notifying its distributors and customers by letter and is arranging for the return of all recalled products. It is also coordinating returns with retailers, wholesalers and consumers.
Patients on the medications are advised to continue taking the tablets and to contact their doctor for advice. The company said, “the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.”
Cox Media Group