Valsartan was approved by the FDA in 2003 and went off-patent in 2012, and is now contained in many other generic medications, although not all of these drugs are affected by the recall, FDA said.
Here in the U.S., the action includes all versions of Valsartan manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd., as well as the valsartan/hydrochlorothiazide (HCTZ) version sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
“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. This is why we’ve asked these companies to take immediate action to protect patients,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
In Europe and Asia, Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled over concerns the drugs “do not meet our high quality standards.” Pharmacies in the UK have been advised to recall all batches of Valsartan that contain medicines made by Dexcel Pharma Ltd and Accord Healthcare.
The recall was issued after routine tests identified the presence of N-nitrosodimethylamine (NDMA), an organic chemical that has been classified as a carcinogen (cancer-causing substance). NDMA has been used to manufacture a wide range of products including liquid rocket fuel, softeners and lubricants, among many other products. It can also be unintentionally produced through certain chemical reactions, and is a byproduct from some manufacturing industries, according to the U.S. Department of Health and Human Services (HSIS).
Studies have demonstrated that NDMA can be toxic to the liver, kidney and respiratory tracts of animals, that that it may also be harmful to humans in sufficient quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen, HSIS said.
Novartis spokesman Eric Althoff said after the initial recall last week that Valsartan products sold in the U.S. were not affected by the recall, but the FDA’s ongoing review and laboratory tests found otherwise. “The presence of of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA release said.