In July, the FDA recalled the blood pressure medication valsartan due to concerns over the drug being tainted with a compound that could lead to increased cancer risks in patients.
Now, according to a CNN report, the FDA expanded the recall to include other blood pressure and heart failure drugs that contain valsartan as well as hydrochlorothiazide. A total of 22 additional countries have also recalled the drugs. The FDA has not recalled all medications that include valsartan, though.
Drugs added to the recall list were manufactured in India by Hetero Labs Ltd. under the name Camber Pharmaceuticals Inc. after testing showed some of the products might be contaminated by N-nitrosodimethylamine or NDMA, which is a compound found in some of the pharmaceuticals containing valsartan. The U.S. Environmental Protection Agency considers NDMA a possible carcinogen.
Medications on the FDA’s updated recall list include those manufactured by “AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).”
The U.S. Food and Drug Administration has expanded its recall of a commonly used type of heart drug because some of the products may contain a potentially cancer-causing chemical. https://t.co/US5kx81TF4— CBS This Morning (@CBSThisMorning) August 7, 2018
The recall only includes medications suspected of having been contaminated with NDMA, which are linked to a Chinese-based manufacturer named Zhejiang Huahai Pharmaceuticals, in Linhai, China. According to the company, they notified authorities as soon as they learned that their drug might have been contaminated by NDMA.
In a statement last month, Zhejiang Huahai Pharmaceuticals said, “We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time… all the drug materials for the Chinese market were recalled by July 23.”
In addition to the recall, the FDA is also actively working with manufacturers to make sure that the active ingredients in valsartan are not at risk of contamination.
In the United States, nearly one in every three adults suffer from high blood pressure, according to a CDC report, which adds up to some 75 million people who may take some form of medication for the condition.
For patients who find their drugs on the valsartan recall list, the FDA recommends they continue taking the medication as prescribed until their doctors or pharmacists give them a replacement form of the medicine. Those who are worried should contact their doctors about the possible risk from the medication and about options for switching to something else.