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A pharmacy warned the Food and Drug Administration that it found a chemical believed to cause cancer in a widely used blood pressure medication, according to a filing from the federal agency.
Valisure, an online pharmacy company licensed in 37 states, told the FDA last week that high levels of dimethylformamide were found in valsartan, a drug produced by Swiss drugmaker Novartis and other pharmaceutical companies. The drug is used to treat hypertension in adults. The World Health Organization classifies dimethylformamide, or DMF, as a probable human carcinogen.
Valisure ask that the medication be recalled and requested that the FDA review and significantly lower the acceptable intake of DMF from its current level of 8,800,000 nanograms to less than 1,000 nanograms. The online pharmacy said it found the cancer-causing chemical in valsartan produced by five companies.
In a statement to CNBC, a spokesperson for Novartis said the company cannot currently fully “exclude the possibility that traces of DMF (within applicable limits) may have been present in materials of other Drug Substances suppliers.”
“The quality and safety of all our products is of the utmost importance to Novartis,” the spokesperson added.
The FDA did not immediately respond to CNBC’s request for comment.
Several blood pressure drugs have already been recalled due to concerns about other cancer-causing chemicals. Earlier this month, Israel-based Teva Pharmaceuticals said it would expand a recall of its heart medication, losartan potassium, after a carcinogen known asN-Nitrosodimethylamine, or NMBA was detected. Torrent Pharmaceuticals in April said it would also recall losartan and Camber Pharmaceutical told the FDA in February it would recall the drug.
CNBC.com
