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The recalled batch will include "Westminster Pharmaceuticals" and "GSMS Inc." on the label, according to the FDA's list.
Irbesartan is an antagonist of angiotensin II receptors, or ARBs. It is a drug that blocks a chemical substance in the blood, called anigiotensin, which causes the contraction of the muscles surrounding the blood vessels from the receptors of angiotensin II. When the chemical binds, it narrows the vessels, which can cause high blood pressure.
FDA tests have shown that the recalled batches of these drugs contained N-nitrosodiethylamine or NDEA, a suspected carcinogen for humans and animals, used in gasoline as a stabilizer for humans. industrial products and as a lubricant additive, according to the National Institutes of Health.
This is the first non-valsartan drug that, according to the agency, contains the NDEA impurity.
Several pills containing valsartan have been recalled since July. The drugs were contaminated with NDEA or NDMA, N-nitrosodimethylamine, an impurity that is also considered a possible carcinogen by the US Environmental Protection Agency.
NDMA is an organic chemical used in the manufacture of liquid rocket fuel and a by-product of the manufacture of certain pesticides and fish processing. It can be introduced unintentionally into the manufacture through certain chemical reactions.
The FDA tests all ARAs for these impurities. He had to design a special test after learning that some ingredients imported from a company in China, Zhejiang Huahai Pharmaceuticals, were contaminated.
The FDA placed Zhejiang Huahai Pharmaceuticals on an import alert at the end of September, which means that all active pharmaceutical products and finished products manufactured by the company will not be allowed to enter the United States. United. The FDA made this decision after its recent inspection of the facility.
Aurobindo, which manufactures the ingredient from ScieGen's irbesartan products, recalls all unexpired lots of its irbesartan API supplied to the US market with NDEA. FDA and Aurobindo laboratory tests have confirmed the presence of NDEA in some batches of their irbesartan IPA.
All drugs containing valsartan or irbesartan are not recalled. According to the FDA, this recall concerns about 1% of drugs administered with irbesartan in the US market.
Talk to your doctor or pharmacist before switching to another medicine. Because not all valsartan and irbesartan drugs involved in the recall, you may be able to switch to a version of another company. The FDA maintains a second list of non-recalled valsartan products.
If your medicine is on the recall list, the FDA suggests taking it until your doctor or pharmacist replaces it.
It is not clear what the risk of cancer is if you are taking valsartan or contaminated irbesartan. pills; the FDA felt that the risk was low with the recall of valsartan. He estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) containing NDMA in these recalled batches for four years, there could be a new cancer case in the lifetime of 8,000 people . Many patients take a much lower dose of valsartan, and therefore their risks are theoretically much lower.
The FDA has announced that it will continue testing all products containing valsartan and similar drugs for the presence of impurities.
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