The drug is being recalled because the drug has been tested positive for N-nitrosodiethylamine or NDEA, a suspected human and animal carcinogen used as a stabilizer in gasoline industrial grade materials and as a lubricant additive, according to the National Institutes of Health.
The ingredient was made by Zhejiang Huahai Pharmaceutical Company Co., Ltd. manufactured. The FDA has alerted the Chinese company to an import warning at the end of September, which means that its active pharmaceutical and finished products are not allowed to enter the United States. The FDA made this decision after an inspection of the facility.
Several pills containing valsartan, another drug used by heart patients, have been recalled since July. The drugs were contaminated with NDEA or NDMA, N-nitrosodimethylamine, a contaminant considered by the US Environmental Protection Agency to be a potential carcinogen.
NDMA is an organic chemical used in the production of liquid rocket fuel and is a byproduct in the manufacture of some of these substances pesticides and fish processing. It can be inadvertently introduced into production through certain chemical reactions.
The FDA tests all known as ARBs heart medications for these impurities.
Not all medicines containing valsartan are being recalled. The FDA keeps a rolling list of recalled products and a list of Valsartan products that are not recalled.
The latest recall, according to the FDA, is less than 1
If your medicine is on the recall list, the FDA recommends it until your doctor or pharmacist provides a replacement. Since not all valsartan and irbesartan medicines are involved in the recall, you may be able to switch to a different company version.
It is unclear what the cancer risk is when you take the contaminated valsartan pills. The FDA said the risk was low with the recall of valsartan.
She estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) daily with NDMA from these recalled batches for four years, an additional case could occur over the life of 8,000 people. Many patients take a much lower dose of valsartan, and therefore their risks are theoretically much lower.
The FDA said it will continue to check all products containing valsartan and similar drugs for contamination.
The CNN Wire
& 2018 Cable News Network, Inc., a Time Warner company. All rights reserved.