FDA testing levels of carcinogen in diabetes drug metformin

FDA testing levels of carcinogen in diabetes drug metformin


(HealthDay)—Levels of possible cancer-causing chemicals in metformin diabetes medications are under investigation by the U.S. Food and Drug Administration.

During the past year and a half, several types of drugs—including angiotensin II receptor blockers and ranitidine (Zantac)—have been found to contain small amounts of genotoxic substances called nitrosamines, such as N-nitrosodimethylamine (NDMA). Exposure to genotoxic substances above acceptable levels over long periods may increase the risk for cancer, the FDA said.

The FDA has been investigating the presence of nitrosamines in other drug products, and some metformin diabetes medicines in other countries were reported to have low levels of NDMA, according to Janet Woodcock, M.D., director of the FDA Center for Drug Evaluation and Research. But NDMA levels in metformin drugs abroad are within the range that naturally occurs in some foods and in water, she noted. Nonetheless, regulators in some other countries are recalling certain metformin drugs, Woodcock said. No metformin recalls affect the U.S. market at the moment.

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