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In the United States, additional shortages of antihypertensive drugs are possible following recent recalls linked to traces of a probable carcinogen found in some versions of a particular clbad of antihypertensive drugs, the Food and Drug Administration said Friday.
Drugs, including valsartan, belong to a clbad of drugs widely used to treat high blood pressure, called angiotensin II receptor antagonists, or ARBs. Valsartan is the generic Novartis Diovan.
The FDA also said it may have identified the root cause of potentially carcinogenic impurities, but that it is continuing its research.
The recalls began last summer after the FDA learned that ingredients used by the Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co (Huahai) to produce valsartan contained impurities. The FDA subsequently stopped all imports from one of Huahai's factories.
Other manufacturers also had to recall valsartan after discovering the impurities in their version of the drug.
It is currently listed as in short supply by the FDA.
Generic drugs
Some generic versions of other ARBS, such as losartan and irbesartan, have also been recalled. The most recent recall was announced earlier this week.
The agency stated that it had determined that impurities "could be generated when specific chemicals and reaction conditions are present in the manufacturing process" and "could also result from the reuse of materials, such as solvents ".
Solvent reuse is an accepted practice in the industry, but manufacturers are generally required to ensure that reused materials meet certain safety standards.
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