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Don't Use Recycled Raw Materials In Valsartan And Other ARBs, US FDA Says

 
• By Joanne S. Eglovitch

US FDA officials told manufacturers to beware of using reused solvents and catalysts to avoid carcinogenic impurities such as nitrosamines from leaching into valsartan and other ARBs used to treat high blood pressure. FDA has identified 40 nitrosamine-free ARBs to provide alternatives to patients and health care providers experiencing shortages caused by recent recalls of these products.

Blood pressure

US FDA officials told manufacturers that nitrosamine impurities can form during processing of active pharmaceutical ingredients in making angiotensin II receptor blockers (ARBs) when raw materials such as solvents and catalysts are used on equipment that has not been cleaned or if these materials have been recycled or reused.

The agency also advised manufacturers of these products to test a representative sample for batches produced for the US market to determine whether they contain a detectable amount of nitrosamine impurities, and has identified and published a

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