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Video: FDA Declares Unacceptable Levels Of Carcinogens In Diabetes Drugs
FDA declares unacceptable levels of carcinogens in diabetes drugs
The US Food and Drug Administration has recommended five pharmaceutical companies to recall metformin drugs.
Photo: Azaria E. Foster
According to the FDA, an independent review has shown elevated levels of the carcinogen N-nitrosodimethylamine (NDMA) in some long-acting metformin drugs. These are prescription drugs used to control high sugar levels in type 2 diabetes patients.
The FDA has not yet named the pharmaceutical companies that have been recommended to withdraw the drug, a statement about this will be published shortly. The agency's message also indicates that these are not the only manufacturers of metformin, and the recall is not recommended for other companies that provide a significant portion of the market in the United States. The FDA notes that testing has not confirmed elevated levels of NDMA in rapid-release metformin, the most commonly prescribed form of metformin.
“We understand that people may have concerns about 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 patients and healthcare professionals with clear and accurate answers to their questions,” - said Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research.
The FDA recommends that patients with type 2 diabetes continue to take metformin tablets even after drug withdrawals until another medication is determined by their healthcare provider. Healthcare providers must also continue to prescribe the drug, as abandoning metformin puts the patient's life and health at risk.
All manufacturers of long-acting metformin are encouraged to test the NDMA level of each batch that is about to go to market.
The increased levels of the carcinogen N-nitrosodimethylamine (NDMA) led to the complete withdrawal from the market of the heartburn drug ranitidine, known under the brand name Zantac, in early April. An FDA study found that impurities in some ranitidine products increase over time.