Valisure Finds Another Carcinogen in Blood Pressure Medicine Valsartan, dimethylformamide (DMF)

The most used blood pressure medicine Valsartan, seem to attract troubles like a magnet does iron particles. The newest trouble is a solvent called dimethylformamide or commonly known as DMF, is classified by the World Health Organization as a probable carcinogen. The FDA allows drugs to contain the equivalent of about 8.8 million nanograms of daily exposure to DMF. The agency last revised its allowable solvent levels in 2017; the WHO classified DMF as a probable carcinogen in 2018.

A solvent called dimethylformamide was discovered in the drug valsartan made by several companies, including Swiss pharmaceutical giant Novartis AG, and some companies that were deemed safe by FDA after the recent recalls of valsartan, according to a filing last week to the Food and Drug Administration by New Haven, Connecticut-based Valisure.
Valisure runs an FDA registered facility and its results were verified by Emery Pharma, an FDA-registered research lab in Alameda, California.

“Medicines are kind of like used cars: By the time you get it it’s already five or six years old, it’s touched hundreds of hands and it’s got 100,000 miles on it,” Valisure Chief Executive Officer David Light said in an interview.

Once facts were revealed, none denied the possibility of contamination. Some drugmakers whose pills tested positive for DMF said that neither they nor the outside companies that produce active ingredients for their drugs use the solvent, though some indicated they don’t have complete visibility into their supply chain. Some of the valsartan that was positive for DMF was on a list of medicines the FDA had earlier deemed safe to use amid the recalls, including drugs manufactured by Alembic Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., both based in India.

Alembic doesn’t use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. A representative for Macleods couldn’t be reached for comment.

“Novartis cannot currently fully exclude the possibility that traces of DMF (within acceptable limits) may have been present in materials” provided to their suppliers, said Novartis spokesman Eric Althoff in an email.

FDA is investigating the Valisure report at the moment. In the meantime these Valsartan had the highest levels of DMF;







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