Several medications containing the active ingredient valsartan are being recalled after the Food and Drug Administration (FDA) announced that these drugs contain N-nitrosodimethylamine (NDMA), an impurity classified as a probable human carcinogen.
The recalled medications include Valsartan Tablets manufactured by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as Valsartan/Hydrochlorothiazide Tablets from Solco Healthcare and Teva Pharmaceuticals. “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.”
As valsartan is used to treat various cardiovascular conditions including heart failure and hypertension, patients should continue to take their medications until they have a replacement product. Not all valsartan-containing medications are part of this recall; patients should contact the pharmacy that dispensed the medication to see if the drug came from a lot specifically manufactured by a company mentioned above.
Healthcare professionals are urged to report any potential side effects related to this recall to the FDA’s MedWatch Program. In the meantime, the Agency plans to continue its investigation into the possible effects NDMA might have on patients who have been taking these products. Addressing a possible shortage due the recall, FDA Commissioner Scott Gottlieb, MD, said “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.”
For more information visit FDA.gov.