On November 20, 2018 the FDA announced another recall for the drug Valsartan due to trace amounts of an impurity that has been called a probable human carcinogen. Mylan Pharmaceuticals announced that large lots of Valsartan-containing products would be voluntarily recalled, including lots of Amlodipine and Valsartan Tablets, USP, Valsartan Tablets, and Valsartan and Hydrochlorothiazide Tablets. These products are being recalled because of detected certain amounts of N-nitrosodiethylamine (NDEA). NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. The Miami Herald reports that “NDEA has been classified as a probable cancerous ingredient by the International Agency for Research on Cancer."
Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infection. This recall is now the sixth Valsartan blood pressure drug to be recalled because of impurities with the Valsartan active ingredient manufactured in Mylan, India. The sudden rush of recalls because of ingredients made overseas has put more scrutiny on these foreign labs and on the FDA’s ability to effectively monitor their products for safety.
If you are a patient who takes Valsartan, it is encouraged that you speak to your doctor about whether your drug is on the recall list before changing a routine with your medicine. Not all Valsartan drugs have been recalled, and your physician may be able to switch you to a version of the drug made by another company. Millions of Americans take some form of blood-pressure medication containing Valsartan, and it is unknown the exact amount of patients that could be affected by this contamination.
Potential injuries as a result of Valsartan contamination:
If you or a loved one has sustained an injury as a result of a Valsartan drug impurity, please contact the attorneys at Montgomery & Ponder, LLC immediately at (205) 377-5004.