The recall contains some Sandoz tablets of losartan potassium hydrochlorothiazide 100 mg / 25 mg tablets with lot number JB8912.…
The recall contains some Sandoz tablets of losartan potassium hydrochlorothiazide 100 mg / 25 mg tablets with lot number JB8912. Patients use these drugs to maintain their high blood pressure in control.
The drug is withdrawn because the active ingredient has tested positive for N-nitroso diethylamine or NDEA, a suspected human and animal carcinogen used in petrol as a stabilizer for industrial materials and lubricant additive according to the National Institute of Health.
Ingredient was made by Zhejiang Huahai Pharmaceutical Company Co. Ltd. The FDA left the Chinese company in an import alert at the end of September, meaning that all of its active drugs and finished products may not enter the United States. The FDA took the decision after an inspection of the plant.
Several pills containing valsartan, another drug used by cardiac patients, have been recalled since July. The drugs were troubled with NDEA or NDMA, N-nitrosodimethylamine, a impurity that is also considered a potentially carcinogenic substance by the US Environmental Protection Agency.
NDMA is an organic chemical used to produce liquid rocket fuel and is a byproduct of the production of certain pesticides and processing of fish. It may inadvertently be introduced into manufacturing through certain chemical reactions.
The FDA tests all heartbeat called ARB for these contaminants.
Not all medicines containing valsartan are withdrawn. The FDA keeps an ongoing list of recalled products and a list of non-recalled valsartan products.
The latest recall affects less than 1
% of total drug release products on the US market, according to the FDA.
If your medicine is on the recall list, the FDA suggests that you take it until your doctor or pharmacist returns. Since not all valsartan and irbesartan drugs are involved in the recall, you may be able to switch to a version of another company.
It is unclear exactly what cancer is if you take the contaminated valsartan pills. The FDA believed that the risk was low in valsartan recall.
It was estimated that about 8,000 people took the highest dose of valsartan (320 milligrams) containing NDMA from these withdrawn rates daily for four years, there may be another case of cancer over the lifespan of 8,000 people. Many patients take a much lower dose of valsartan, and their risks are therefore theoretically much lower.
The FDA said it continues to test all products containing valsartan and similar drugs for contamination.