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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.
Recovering compensation after an injury from a defective product
It is a manufacturer’s responsibility to make sure their products are safe for consumers. If someone is injured due to a defective product, a product liability claim may exist. A claim may be pursued to pay for damages caused by the defective product such as medical bills, missed time from work and pain and suffering.
If you or someone you know has been seriously injured by a defective product, it is important to contact a personal injury attorney to review your rights. Call 412-661-1400 to schedule a free consultation with a personal injury lawyer in Pittsburgh at Berger and Green today.
Source: WebMD, “Metformin Recalled for Possible Cancerous Chemical”
Regulatory Focus, “FDA recalls some ER metformin for NDMA impurity”