Testing Indicates Metformin Products May Cause Cancer
Recent testing indicates some metformin products may be tainted with a probable human carcinogen. You may be eligible to file a metformin lawsuit if you or a loved one were diagnosed with cancer following treatment with this widely-used Type 2 diabetes medication.
Metformin is an oral medication used to control blood sugar in adults and children over 10 who suffer from Type 2 diabetes. Approved by the U.S. Food & Drug Administration (FDA) in 1994 under the brand name Glucophage, metformin is now sold under several brand names, including:
- Glucophage XR
Numerous drug makers also market generic versions of metformin in the United States.
Metformin is considered the front-line treatment for Type 2 diabetes. It is also used to prevent Type 2 diabetes, treat gestational diabetes, manage antipsychotic-induced weight gain, and treat/prevent polycystic ovary syndrome (PCOS).
In 2017, pharmacies in the United States dispensed 78,602,870 metformin prescriptions.
Metformin Recalls Around the World
In December 2019, three types of metformin were recalled in Singapore after the drugs were found to contain high levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
In February 2020, two additional metformin recalls were announced in Canada due to NDMA contamination:
- February 5th: Apotex recalled certain lots of Metformin ER (extended release) 500 mg tablets
- February 26th: Ranbaxy Pharmaceuticals recalled 6 lots of metformin
Metformin investigations into possibly tainted drugs have also been launched in the United States and the European Union.
Valisure Petitions FDA for Metformin Recall
While the FDA’s tests did detect NDMA in some metformin samples, the agency ultimately reassured the public that the levels found were well below the current recommended intake level of 96 nanograms per day. As a result, there were no metformin recalls in the United States.
In March 2020, however, Valisure — an online pharmacy that tests every batch of drugs it sells – announced that its own testing program had detected high levels of NDMA in 16 of 38 metformin batches. The highest levels were found in Amneal Pharmaceutical’s metformin, which in some cases contained as much as 16-times the FDA’s recommended daily limits. Several companies’ metformin contained more than 10 times the limit.
Valisure also sent a petition to the FDA demanding that the agency order a metformin recall for the affected batches. While the FDA is reviewing Valisure’s petition, it has yet to request any recalls.
Months earlier, Valisure had alerted the FDA to the presence of NDMA in Zantac.
NDMA and Cancer
NDMA was once used to make rocket fuel, but that practice ended after unusually high levels of the compound were found in air, water, and soil samples collected near a rocket fuel manufacturing plant. However, NDMA continues to be an unintentional byproduct of certain manufacturing processes, as well as an environmental contaminant found in water and foods, including meats, dairy and vegetables.
Animal studies have linked NDMA exposure to liver disease, as well as an increased risk of certain tumors, including liver cancer, lung cancer, kidney cancer, and cancers of the gastrointestinal tract.
There are no reports of NDMA causing cancer in humans. But according to the U.S. Centers for Disease Control’s Agency for Toxic Substances and Disease Registry, it is “reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”
The U.S. Environmental Protection Agency has designated NDMA a probable human carcinogen.
Learn If You Qualify to File a Metformin Lawsuit
Our metformin lawyers are offering free, no-obligation legal reviews to individuals – or their surviving family members — who developed cancer following treatment for Type 2 diabetes, including:
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Esophageal cancer
- Bladder cancer