FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock released a statement warning of a shortage of ARBs, or angiotensin II receptor blockers, which contain valsartan.
Last summer, the FDA began reporting that some generic versions of the ARB meds contain nitrosamine impurities, which are probable human carcinogens. The agency initiated voluntary recalls of batches of valsartan, affecting multiple drugmakers such as Teva Pharma, Solco Healthcare, Sandoz and Mylan.
"Currently, valsartan products are in shortage, and we know that other types of products may fall into shortage soon," the agency warned in its most recent statement.
The statement outlined the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues. The FDA said its ongoing investigation had determined the impurities were generated in the manufacturing process and could have resulted "from the reuse of materials, such as solvents."
According to the agency, now that they are aware that certain conditions result in the formation of these nitrosamines, "manufacturers using processes at risk for these impurities are expected to test for them to ensure that active ingredients and finished products are free of detectable levels of a nitrosamine impurities resulting in drug products that that are safe for patients."
