The FDA has issued a voluntary recall of valsartan, due to concerns of an impurity N-nitrosodimethylamine (NDMA), a known carcinogen, which was found in a batch of the drug manufactured in China. Valsartan is commonly used to control hypertension and heart failure.
NDMA can cause cancer—tumors in the liver, kidney and respiratory tract.
The action comes after 22 other countries, including Canada and the UAE, recalled the drug. The FDA initially believed valsartan products sold in the U.S. were not affected.
The U.S. recall includes types of valsartan manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries and valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries.
"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards,” said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. “This is why we've asked these companies to take immediate action to protect patients.”
However, not all products containing valsartan are being recalled. The FDA noted the amounts of NDMA Valsartan API “are much lower than the cumulative endogenous production and usual external exposure of NDMA.”
"The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured," said FDA Commissioner Scott Gottlieb, MD. "When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications."
The FDA advised patients to speak to their physicians if they are taking the recalled medications. They should not discontinue taking medication without a physician’s permission.
As a senior news writer for TriMed, Subrata covers cardiology, clinical innovation and healthcare business. She has a master’s degree in communication management and 12 years of experience in journalism and public relations.