Valsartan Based Drugs Recalled by FDA

July 26, 2018  Source: HealthLine 261


At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced to withdraw drugs containing valsartan, which treat high blood pressure and heart failure. The drugs were withdrawn due to the presence of N-nitrosodimethylamine (NDMA), which might lead to cancer.

Multiple companies such as Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., are withdrawing their drugs containing valsartan. The FDA reported, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”

These affected drugs were generic versions of Diovan, made by Novartis International AG. But the generic versions made by other companies were not included in this recall list.

Dr. Victoria Shin, a cardiologist from Torrance Memorial Medical Center in California said, “It’s not the drug valsartan that’s the problem. It’s a contaminant that was included in the manufacturing process that’s the problem. Patients shouldn’t lose faith in the drug itself.”

CNN reported that the external supplier associated with the NDMA impurity in the recalled products had also stopped distributing valsartan.

The FDA provided instructions issued by the companies regarding how to return or dispose of the affected medicines. Patients should look at the drug name and the listed company on the prescription label to check if their medication has been recalled.

Dr. Victoria Shin said, “patients should not stop their medication on their own without consulting a physician; This can cause elevated and uncontrolled blood pressure which can potentially have severe health consequences.”

The definite level of NDMA which might increases the risk of cancer is still unknown.

By Ddu

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