Carcinogen detected in popular diabetes drug; FDA recall sought

High levels of a carcinogen were found in metformin, a popular drug used to treat diabetes, by Valisure, an online pharmacy that tests drugs before shipping them to customers, Bloomberg reported

Valisure said it found  N-nitrosodimethylamine, or NDMA, a cancer-causing chemical, in 16 different batches of metformin made by 11 drug companies. The highest levels were reportedly found in a batch made by Amneal Pharmaceuticals, with as much as 16 times the acceptable daily limit. 

Metformin is used as an initial treatment for Type 2 diabetes to control high blood sugar levels, Bloomberg reported. It is the fourth most commonly prescribed drug in the U.S. 

The FDA said in December that it was testing diabetes drugs for NDMA after it was found in popular heartburn drugs and that it would recommend recalls as appropriate. 

The FDA recently has tested metformin, but said it found no levels to be higher than the acceptable limit, according to Bloomberg. It is unclear why the FDA's results differ from Valisure's.

Valisure sent the FDA a citizen's petition March 2 asking the agency to recall metformin and conduct an investigation to see how the drug became contaminated. Contamination could have occured because of the manufacturing process, how the drug is stored, or aspects of the drug itself, according to Bloomberg

"The FDA knows that impurities in medicines are of great concern to patients and consumers who rely on safe and effective medicines approved by the FDA, and we are working with manufacturers and global regulators to provide clear and actionable information. We will continue to work with drug manufacturers to ensure safe, effective, and high-quality drugs for the American public," the agency said in a statement to Becker's Hospital Review

Read the full article here

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