The United States Food and Drug Administration (FDA) asked five pharmaceutical companies to voluntarily recall their diabetes medication containing metformin. The FDA is requesting this voluntary recall because traces of a possible carcinogen has been found in some of the medications. The impurity in question is a compound called N-nitrosodimethylamine (NDMA). An FDA agency lab reported that the NDMA rates are above acceptable intake limits after research was conducted on samples of the drug metformin.
According to the FDA, the agency is also asking all manufacturers of extended-release versions of metformin to evaluate their risk of excessive NDMA levels. They also instructed them to test the at-risk products before each batch is released to the U.S. market. If testing shows NDMA levels are above the acceptable intake limit, the manufacturer must inform the agency and should not release the batch to the U.S. market. But, the FDA also says that it could be dangerous for people with type 2 diabetes to stop taking metformin without talking to their doctor first.
In December, the FDA started an investigation into metformin. Patients take metformin to treat their type 2 diabetes. There is currently no scientific evidence of how long these levels of NDMA have been present in metformin products. But, the FDA is currently conducting research to find out more information.
What is Metformin?
Metformin is an oral diabetes medication that helps patients with type 2 diabetes control their blood sugar levels. Patients also use insulin or other medications to assist with controlling blood sugar levels due to type 2 diabetes with metformin.
Brands of metformin in the United States include:
- Glucophage XR
To find out if your brand of metformin is on the FDA recall list, check the FDA’s drug recalls page for more information. If your brand of metformin is on the recall list, it is important to talk to your doctor first before you stop taking the drug. They will discuss other treatment options that will be a safe alternative for you or any patient. Once you have a safe alternative given to you by a doctor, patients should return their unused metformin to their pharmacist.
What is NDMA?
NDMA or N-Nitrosodimethylamine is an organic compound that has been studied for toxicity for many years. NDMA is in many common items in small amounts like cured meat, rocket fuel, and drinking water. Most recently, the FDA recalled a popular heartburn drug, Zantac, for having dangerous levels of NDMA which is considered a probable human carcinogen. Additionally, Studies showed that impurity levels rose in NDMA in higher temperatures. Because you cannot always control the temperature of medication in shipping and other factors, the FDA has found the levels of NDMA to be above acceptable levels and unsafe for human consumption. Following the recall, retailers, manufacturers, and doctors had to remove or dispose of the drug. Because of the associated injuries with NDMA contamination, there have been lawsuits against the makers of Zantac.
Common injuries associated with NDMA contamination are:
- Liver cancer
- Stomach cancer
- Prostate cancer
- Small and large intestinal cancer
- Colorectal cancer
- Esophageal cancer
- Bladder cancer
- Non-Hodgkin’s lymphoma
- Multiple myeloma
- Pancreatic cancer
Is There a Lawsuit?
At this time, there are no reports of cancer or any other illnesses developed from taking the diabetes drug metformin. Because the discovery of NDMA in metformin is recent, there are no lawsuits against the makers of metformin at this time. There is a proposed class action, but no definitive class action, mass tort cases, or MDL’s for metformin.