In January of 2021, drug maker Nostrum Laboratories voluntary recalled its popular diabetes drug metformin over concerns that it contained unacceptable levels of a cancer-causing agent. This latest recall involves one lot of 750 mg extended-release tablets. This recall is an expansion of a recall initiated by Nostrum in November of 2020, which involved other lots of the extended-release tablet.
Metformin is a popular diabetes drug that is used to control blood sugar. People with Type 2 diabetes use metformin alone or in combination with other drugs to control their blood sugar levels. It is estimated that about 34 million Americans suffer from Type 2 diabetes.
In May of 2020, the Food and Drug Administration (FDA) advised five drug makers to recall their versions of metformin because several batches of the drug had tested positive for unsafe levels of a chemical called N-nitrosodimethalymine (NDMA). The FDA has stepped up testing drugs for NDMA after the chemical was found in dozens of batches of heartburn medication leading to the recall of Zantac and other drugs.
Since the FDA’s initial notice in May, ten companies have recalled lots of their extended-release metformin. The agency noted that no contamination problems had been found in the immediate-release forms of the drug. After each recall, patients who had been prescribed the drug were advised to keep using it until their doctors prescribed a replacement.
What is NDMA?
NDMA is a substance that has been classified as a probable human carcinogen. However, NDMA is a contaminant that can be found in a variety of things, including water, meat, dairy products, and vegetables. In very small doses, NDMA is not harmful. Its ingestion increases the risk of cancer at high levels or exposure over a long period of time. NDMA can contaminate batches of medication during the manufacturing process or depending on the way it is packaged or stored.
Contact an Experienced Attorney
If you’ve developed cancer after long-term use of metformin, you should have your case evaluated by an experienced product liability attorney. For over 25 years, Gregg Goldfarb has been helping the victims of dangerous drugs. Contact us online or call us at 305-374-7000 to schedule a free consultation.