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Jun 30, 2020
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FDA claims unacceptable carcinogen levels in diabetes medication

The US Food and Drug Administration has recommended that five pharmaceutical companies withdraw metformin drugs.

According to the Office, an independent examination showed an increased level of the carcinogen N-nitrosodimethylamine (NDMA) in some long-acting metformin preparations. These prescription drugs are used to control high sugar levels in patients with type 2 diabetes.

The FDA has not yet named the pharmaceutical companies that are recommended to withdraw the drug; a statement will be published shortly. The agency’s report also indicated that these are not the only manufacturers of metformin, and that other companies that provide a significant part of the US market do not recommend a recall. Management notes that testing has not confirmed an increased level of NDMA fast release metformin drugs — this is the most commonly prescribed form of metformin.

“We understand that people may have concerns about the possible impurities of carcinogens in their medicines, and we want to assure the public that we have carefully studied this problem for many months and are ready to provide clear and accurate answers to patients and medical workers to their questions,” - said the Acting Director of the Center for Drug Evaluation and Research of the Office (FDA's Center for Drug Evaluation and Research) Patricia Cavazzoni (Patrizia Cavazzoni).

Management recommends that patients with type 2 diabetes continue to take metformin tablets even after drug withdrawal until their doctor chooses another medicine. Doctors should also continue to prescribe the drug, as refusing metformin jeopardizes the patient’s life and health.

All manufacturers of long-acting metformin preparations are advised to test the NDMA level of each batch that is preparing to enter the market.

The increased level of the carcinogen N-nitrosodimethylamine (NDMA) was the reason for the complete withdrawal from the market of the drug for heartburn ranitidine, known under the brand name Zantac in early April. An FDA study found that the content of impurities in some ranitidine products increases over time.



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