Mylan Pharmaceuticals is expanding its recall of high blood pressure and heart failure treatments to include all its products that contain the active ingredient valsartan because they may contain trace amounts of a potentially cancer-causing impurity.
The 104 additional lots involved in the recall include varying doses of 26 lots of amlodipine and valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan and hydrochlorothiazide tablets. The tablets were distributed nationwide from March 2017 to November 2018. A list of affected drugs can be found on Mylan’s recall notice.
The impurity found in the drugs is N-nitrosodiethylamine (NDEA), and the medications were manufactured by Mylan Laboratories Limited. The substance occurs naturally in foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC).
Valsartan is used to treat high blood pressure and heart failure, and to reduce cardiovascular mortality following a heart attack. In combination with amlodipine or hydrochlorothiazide, it is used to treat high blood pressure. Valsartan is in a class of drugs called antiotensin receptor blockers, or ARBs.
In recent months, several recalls were initiated for valsartan from various manufacturers due to NDEA contamination. Last month, another ARB, Irbesartan, was recalled after it was found to contain the same possible carcinogen.
Patients taking these drugs should not stop taking them without first talking with their doctor and discussing an alternative treatment.
FDA Safety Communication