According to the US Food and Drug Administration, another heart drug was voluntarily recalled after tests showed it was infested with a potential cancer-causing chemical.
The new recall of losartan potassium hydrochlorothiazide is being sold by Sandoz. Voluntary recall only affects the 100 milligram / 25 milligram tablets, but not the other versions of the medicine, sometimes sold under the Hyzaar brand name. If you are taking Sandoz's Losartan Potassium, note the lot number of the bottle. If it has lot number JB8912 then you have the recalled pills. Patients use these medications to keep their high blood pressure at bay.
The drug is being recalled because the drug has been tested positive for N-nitrosodiethylamine or NDEA, a putative 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 developed by Zhejiang Huahai Pharmaceutical Company Co., Ltd. manufactured. The FDA has alerted the Chinese company to an import warning at the end of September 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 contaminants.
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 most recent recall concerns 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 claimed that all products containing valsartan and similar medicines continue to be tested for impurities.