The United States Food and Drug Administration posted, this week, a statement from Teva Pharmaceuticals USA regarding a voluntary recall into two high blood pressure drugs over increased concern of a possible cancer risk. In the statement, Teva Pharmaceutical’s recall affects all 30- and 90-day lots of medication tablets which feature a combination of amlodipine and valsartan as well as another tablet combination that features amlodipine and valsartan and also hydrochlorothiazide. It seems there are 48 lots in total listed in the recall, with expiration dates between 11/2018 and 4/2019.
It is important to note that the recall effort is not necessarily over concerns of the drugs themselves. The recall suggests that these combination tablets might contain an impurity known as N-nitroso-diethylamine (NDEA). NDEA has been classified as a potential human carcinogen. This chemical is actually commonly found—in very small amounts—in certain foods, as well as in our drinking water, air pollution, and in some industrial processes.
This is actually the latest recall over such concerns. You may recall, in August, the FDA announced the expansion of an existing recall of valsartan products because they had been suspected of the impurity. Then last month, the FDA announced two additional recalls—one for irbesartan and another for losartan potassium hydrochlorothiazide tablets—marking several possible medication risks over the same cancer concerns.
According to the Medicines and Healthcare products Regulatory Agency (MHRA), only drugs [with these ingredients] under the brand names Mylan and Teva are affected (and thus included in the recall). The MHRA also reports that there has been no evidence of harm to patients by the dugs in question.
In any sense, any person who is taking either of the two drugs listed in the recall is advised to contact their doctor or pharmacist to find an alternative treatment. This is the correct avenue because it is also the safest: simply stopping treatment with these drugs without a suitable replacement could actually pose a greater risk than continuing to take the drugs.
Teva also advises that any patient who has questions or concerns can contact the drug company by phone at 888.838.2872 or by email at [email protected]