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FDA Warns Recalls Causing Shortage of Common Blood Pressure Drug


By Jonathan Block

January 28, 2019

FDA Warns Recalls Causing Shortage of Common Blood Pressure Drug

The FDA is warning that there is a shortage of the commonly prescribed blood pressure drug valsartan due to ongoing manufacturing issues in which the drug is being contaminated with a possible carcinogen. The agency also said other angiotensin receptor blockers (ARBs), such as losartan and irbesartan, may become in short supply too.

Since the summer, the FDA has issued recalls for all three drugs – though valsartan has been impacted the most – from some generic manufacturers. Most of the recalled valsartan was made in China. The recalled drugs contain potentially dangerous contaminants, N-nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA) , which laboratory studies have shown can cause cancer or liver damage.

“Valsartan products are in shortage, and we know that other types of products may fall into shortage soon,” FDA Commissioner Scott Gottlieb said in a statement.

“We remind patients taking these medications or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option,” he added.

Going forward, the FDA’s focus “is to balance the risk of patients ingesting low levels of the impurities (below the interim acceptable levels) for a short period of time with the risk that there is a shortage.”

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Last updated: January 28, 2019