Metformin Recall Continues After NDMA Contamination Detected
Drug manufacturers are moving forward with continued metformin recalls after the Food and Drug Administration (FDA) recently announced the popular diabetes medicine is contaminated with NDMA, a potentially cancer-causing chemical.
India-based manufacturer Marksans Pharma Limited joins seven other pharmaceutical companies that have issued metformin recalls due to NDMA contamination. The FDA has asked all manufacturers of extended release (ER) metformin to evaluate the safety of these drugs to determine if NDMA levels exceed the acceptable limit.
If levels of NDMA are determined to exceed the FDA’s acceptable limit, manufacturers are required to notify the FDA and cease selling the contaminated product immediately.
The FDA is currently investigating how NDMA ended up in metformin. For more information on the FDA’s investigation into metformin, please visit their FAQ page.
What is Metformin?
Metformin (metformin hydrochloride) is used to treat type 2 diabetes and is designed to lower glucose levels.
Metformin is the most commonly used oral medication for treating diabetes. In 2017, metformin was the fourth most prescribed medication in the United States, with an estimated 78 million prescriptions written.
While metformin is available as a generic medication, it is also sold under the brand names Glucophage, Glucophage XR, Fortamet, Glumetza, and Riomet.
What is NDMA?
N-nitrosodimethylamine (NDMA) is classified as a “probable carcinogen,” meaning that it is known to cause cancer in humans. It is the same dangerous chemical that has been found in Zantac (rantidine), resulting in a major FDA recall and roughly 20,000 lawsuits alleging Zantac causes cancer.
According to the FDA, “We do not know how long patients may have been exposed to higher NDMA levels in ER metformin.” However, scientific research has established a connection between NDMA and as many as 20 different types of cancer, including esophageal cancer, stomach cancer, bladder cancer, liver cancer, pancreatic cancer, and intestinal cancer, to name a few.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above acceptable levels over long periods of time.”
-FDA Statement on NDMA Contamination in Metformin
“How do I know if my metformin medication has been recalled?”
If you take metformin, the FDA encourages you to check out its drug recalls database to determine if your medication is subject to a recall.
“I take metformin. What should I do?”
If your metformin medication is under recall, the FDA encourages you to check with your doctor for a potential alternative treatment option. The FDA does NOT advise patients to stop taking metformin without first consulting their doctor, as immediately stopping this prescription may be dangerous.
The FDA encourages patients to return any unused metformin to their pharmacist.
IMPORTANT: Check with your doctor before you stop taking metformin as stopping immediately may be dangerous to your health.
While our firm is not currently accepting metformin cases, legal action against metformin manufacturers is underway.
Riddle & Brantley may accept metformin cancer cases in the future. For the latest developments, please stay tuned to our blog.