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Another carcinogen in popular BP drugs

19th June 2019 – An online pharmacy claimed to have found a potentially carcinogenic chemical in some amounts by Valsartan, a multi-drug prescription medicine. Many of the companies are on an FDA list of safe medicines after the authorities recalled dozens of blood pressure medicines for contamination with other possible substances that cause cancer or carcinogens. The FDA says that these batches were largely contaminated during production at plants in China and India. So far, Valsartan batches identified by Valisure have not been recalled.

In a citizen petition to the FDA on June 13, Valisure reported that high levels of a chemical called N, N-dimethylformamide (DMF) were found in certain batches of the drug. Valisure says it independently tests every drug it sells, thus finding the problem.

DMF is a solvent used in the manufacture of pharmaceuticals. The World Health Organization classifies it as a probable human carcinogen, and Valisure's petition calls for the FDA to recall these valsartan batches.

According to an FDA spokesman, "more than 1

00 DMF levels are reported to be lower than those set by international standards to alarm patients. "Valisure's tests showed ranges of DMF from below 100 nanograms to over 80,000 nanograms per pill, while the current allowable value is 8.8 milligrams (8.8 million nanograms) per day. In its petition, Valisure also urged the FDA to drastically lower the allowable amount to more in line with the chemicals that have led to earlier recalls.

If you take Valsartan and are worried, do not stop taking the medicine. Talk to your pharmacist or call the FDA Center for Drug Evaluation and Research at toll free number 855-543-3784.

For more information on previous blood pressure drug recalls, see the comprehensive WebMD coverage here.





Regulations.gov: "Citizen Petition from Valisure," June 13, 2019.


Jeremy Khan, FDA spokesman

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