Metformin is a popular prescription drug used to treat type 2 diabetes. Type 2 diabetes affects the normal production and release of insulin, a hormone that allows the body to metabolize food and convert it to energy. Doctors prescribe the diabetes drug to reduce the amount of sugar the liver releases and improve how the human body responds to insulin.
The goal with taking Metformin is to control blood sugar levels. The diabetes drug Metformin also goes by its brand name of Glucophage. Because Glucophage costs significantly more, doctors typically choose to prescribe Metformin instead. More than 120 million people across the world currently take Metformin in pill form to control their blood sugar. The U.S. Food and Drug Administration (FDA) approved Metformin to treat type 2 diabetes in the 1990s.
FDA Announced Voluntary Metformin Recall
On October 5, 2020, the FDA announced two voluntary Metformin recalls due to concerns about unsafe levels of n-nitrosodimethylamine (NDMA), a probable human carcinogen. The most recent FDA recall notice references extended-release (ER) Metformin tablets sold by Sun Pharmaceutical Laboratories and Marksans Pharma. The most recent voluntary Metformin recall is in addition to the hundreds already included on the FDA List of Recalled Metformin Products. Amneal Pharmaceuticals and Granules Pharmaceuticals have hundreds of batches of Metformin included on the list.
Have you taken a Metformin product and later developed one of these types of cancer?
- Bladder cancer
- Colon cancer
- Esophageal cancer
- Intestinal cancer
- Kidney cancer
- Liver cancer
- Pancreatic cancer
- Stomach cancer
If so, it may be due to high levels of NDMA in the Metformin product prescribed to you.
What is N-nitrosodimethylamine (NDMA)?
NDMA is a nitrosamine used as part of the ingredients to create Metformin and brand name Glucophage. Nitrosamine is a chemical and can be a contaminant. While NDMA was once an ingredient in rocket fuel, the Environmental Protection Agency (EPA) stopped that practice because the compound made its way into soil, air, and water near the plant that manufactured rockets.
Today N-nitrosodimethylamine is only a byproduct in some manufacturing processes. The EPA reports that scientists in research laboratories use NDMA to purposefully create tumors in animal test subjects to help them study the effects of cancer and its various treatments. Because it is a carcinogen, the FDA only permits allowable limits of n-nitrosodimethylamine in both food and drugs.
Besides Metformin, Zantac, and other popular prescription drugs, NDMA is present in foods like dairy products, grilled meats, cured meats, fish, and vegetables. Some consumer products, including cosmetics, detergent, deodorant, and tobacco, also contain NDMA. The Agency for Toxic Substances and Disease Registry (ATSDR) reports that some workers in the manufacturing industry face NDMA exposure on the job. Because the FDA deemed it impossible to eliminate MDMA altogether, it considers 96 nanograms a reasonably safe amount.
To put it in perspective, 96 nanograms is equivalent to approximately one billionth of one gram. Any levels of NDMA over that amount can be dangerous and cause an increased risk of cancer. Your risk of developing cancer is highest if you took Metformin with NDMA contamination over a period of time. N-nitrosodimethylamine, a known carcinogen to animals for many years, is now a probable human carcinogen as well according to the EPA, ATSDR (operating under the direction of the Centers for Disease Control), and World Health Organization (WHO). The FDA first discovered that some manufacturers produced batches of Metformin with high levels of NDMA in them in late 2019.
Studies of Metformin NDMA Risks by the FDA and Online Pharmacy Valisure
In February 2020, the FDA posted laboratory results after evaluating 16 batches of Metformin from seven drug makers. The FDA concluded at that time that all batches of Metformin contained an acceptable level of NDMA. Critics of the FDA study concluded that drug makers submitted batches of Metformin to the NDMA voluntarily and raised concerns about a possible sampling bias.
To provide a more complete and independent laboratory study of Metformin products, the online pharmacy Valisure acquired 38 batches of Metformin from 22 drug makers through its pharmacy distribution partners. Valisure determined that 42 percent of the analyzed batches contained unsafe levels of n-nitrosodimethylamine. Armed with this information, Valisure filed a Citizen Petition with the FDA on March 2, 2020. The petition stated that 16 of the 38 batches studied contained unsafe levels of NDMA, with one batch returning results 16 times the daily acceptable limit of 96 nanograms.
Because of the small size of its study and limited options to obtain batches of Metformin from its pharmacy distribution partners, the online pharmacy Valisure ordered a direct-to-consumer crowdsourcing study that evaluated 128 samples of Metformin medication from people who sent them in from 30 different states. The results of Valisure’s second study also indicated a 42 percent rate of NDMA contamination. The highest levels of NDMA detected in the crowdsourcing study were 65 times what the FDA considers an acceptable daily amount.
Because of information released by the online pharmacy Valisure, the FDA conducted a second study. On May 28, 2020, the FDA released its first press release indicating an impurity of nitrosamine in Metformin products, specifically the extended-release capsules. At the same time, the FDA worked closely with the five affected drug makers as they issued voluntary recalls of their Metformin products.
NDMA Contamination and Increased Risk of Cancer
Whether you develop cancer after taking this diabetes drug depends on several individual factors, the biggest being how long you took it and at what dose. We urge you to visit a health care professional if you have any new symptoms beyond the typical side effects of Metformin. Whether you have cancer or not, be sure to ask your health care provider about switching to a different type of medication to control high blood sugar and improve the functioning of your liver and pancreas.
If you do have a diagnosis of cancer, you have the right to file a lawsuit due to a defective drug. The lawsuit would likely be against the drug maker that did not take proper precautions to avoid introducing a probable human carcinogen into its Metformin products. The statute of limitations for filing a defective drug lawsuit depend on the laws in your state.