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Wednesday, June 26, 2019

Another Carcinogen in Valsartan?

According to online pharmacy - Valisure -, a widely used blood pressure medicine – valsartan – contains potential cancer-causing chemicals! Valsartan is manufactured by several pharmaceutical companies and many of the companies whose valsartan is recalled by the FDA recently also appear on the agency’s list of safe medications. The companies include pharmaceutical giants like Novartis AG. The recalled happened because FDA found the medication was contaminated with possible carcinogens.

    According to the FDA, the contamination in those batches of drugs happened during production in China and India. Only the valsartan batches identified by Valisure have not been recalled.

    How was the carcinogen detected

    Valisure sent a citizen petition to the FDA on the 13th of June where they mentioned finding high levels of the chemical N,N-Dimethylformamide (DMF) in certain batches. The pharmaceutical company reportedly tests every drug independently and that is how they were able to discover the grave problem.

    What is DMF

    DMF is a type of solvent used in pharmaceutical production. However, the World Health Organization lists it as a probable carcinogen to humans and thus Valisure’s petition calls on the FDA to recall those batches of valsartan.

    According to some of the drug companies, neither they nor their outside companies use DMF as a solvent to their drugs. However, some of them have admitted that they do not have complete control of the transparency of their supply chain.

    DMF within acceptable range?

    However, according to the FDA, the level of DMF found in those batches of valsartan are more than 100 times less than what is considered harmful by international standards. Valisure‘s tests found DMF levels within the ranges of under 100 nanograms to more than 80,000 nanograms per pill while the current allowed levels if 8.8 milligrams (8.8 million nanograms) per day. In the petition, Valisure also requested to lower the acceptable amount of DMF drastically.

    This is not the first time a carcinogen was found in valsartan. Dozens of forms of generic valsartan have been recalled since July 2018, when the carcinogenic chemical N-Nitrosodimethylamine, or NDMA, was detected in a version of the drug made by a Chinese company.

    What can you do?

    If you are on valsartan are concerned, do not stop taking the drug. Talk to your pharmacist or doctor or call the FDA’s Center for Drug Evaluation and Research’s toll-free number, 855-543-3784.

    That's all for today!
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