- FDA Urges Recall for Five Companies’ Diabetes Drug, Metformin.
FDA Urges Recall for Five Companies’ Diabetes Drug, Metformin.
The FDA has asked five pharmaceutical companies to recall their diabetes drug, metformin.
The FDA has detected higher than acceptable levels of a cancer-causing chemical in a sampling of the medication.
Metformin is used to control high blood sugar in type-2 diabetes. The FDA said they found the chemical in certain extended-release versions of the drug, not the immediate-release versions.
The high-level chemical found in the metformin medications is a type of nitrosamine called nitrosodimethylamine, or NDMA.
NDMA is an environmental contaminant that is found in water and foods, including meats, dairy products and vegetables. However, high levels of N-Nitrosodimethylamine (NDMA), is believed to cause cancer in people.
Currently, the FDA has notified five pharmaceutical companies that the NDMA in their metformin medication has quantities over the acceptable intake limit. Amneal Pharmaceuticals LLC and Apotex Corp are the only two manufacturers listed on the FDA’s website at this time.
The FDA has recommended all five companies voluntarily recall the NDMA-containing metformin formulations
The FDA is continuing to investigate.
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Source: WebMD, “Metformin Recalled for Possible Cancerous Chemical”
Regulatory Focus, “FDA recalls some ER metformin for NDMA impurity”
