- Friday the FDA announced a voluntary recall of some drugs containing valsartan due to an "impurity"
- A week ago the drug was recalled in 22 other countries
Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA
. The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) 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, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan
/HCT film-coated tablets are being recalled because they "do not meet our high quality standards." Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.
The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA)
, which was found in the recalled products, according to an FDA statement.
NDMA is an organic chemical that is in a family of potent carcinogens. It has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.
Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen, according to the US Department of Health and Human Services
Novartis spokesman Eric Althoff said after the initial recall last week that products sold in the US were not affected by this 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 wa