Metformin Recall: Everything You Need to Know

With David Klonoff MD

The widely used drug for type 2 diabetes is being recalled. Here, how to safely reduce your risk.

Type 2 diabetes drug recall

Metformin hydrochloride is the most commonly prescribed medication for glucose management in patients who suffer from type two diabetes.

The latest tablet recall is a voluntary one from Marksans Pharma Limited, which issues metformin tablets marketed as Time-Cap Labs, Inc. Some 178 lots of metformin hydrochloride have been recalled in total from various manufacturers. You can review the entire FDA list here to see if any of the metformin tablets you have on hand come from recalled batches.

Why is metformin being recalled?

The reason for the recall is the detection of high levels of N-nitrosodimethylamine, more commonly known as NDMA, an organic compound linked to causing cancer in high concentrations. Metformin hydrochloride is not the only drug affected by NDMA-related recalls.

What is N-nitrosodimethylamine?

N-nitrosodimethylamine is the scientific word for nitrosamine, which is an organic compound found in cured and grilled meats such as bacon, dairy products, and fried foods. It’s also been discovered in fermented foods like beer. The compound is in smoke and tobacco products, as well as in shampoos, pesticides, and cleaning detergents. The levels of NDMA found in these items is generally not cause for concern, as the level and duration of ingestion of this compound is what makes it harmless or toxic.

“Everyone is exposed to some level of nitrosamines,” explains endocrinologist David Klonoff MD, Medical Director of the Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Medical Center in San Mateo, California, and a clinical professor of medicine at UCSF. “Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”

Why is NDMA found in metformin?

Just as NDMA is formed after some water treatment processes, it could also form during drug manufacturing processes. The ingredients used to manufacture metformin could be contaminated. Solvents, for example, could potentially contaminate batches and the contamination may go undetected in the purification process. There’s no definitive answer as to why medications are seeing higher than acceptable levels of a group 2A carcinogen. In fact, there’s no direct evidence that links NDMA to cancer in humans. It’s probable though, because that link has been made in animals.

What should I do if my metformin tablets are on the recall list?

Only extended release tablets in doses of 500 to 750 mg are affected by these recent recalls. Immediate release tablets have not been found to contain high levels of NDMA. Even if you have tablets that appear on the recall list, it’s important to keep taking them until you can get a new prescription or alternative form of treatment for glucose management from your doctor.

“It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” explains Dr. Klonoff.

If you’re concerned about taking metformin tablets as part of your treatment, there are other options. According to Dr. Klonoff, alternatives to metformin include sulfonylureas, meglitinides, thiazolidinediones (TZDs), alpha glucosidase inhibitors, dipeptidyl peptidase IV (DPP-4) inhibitors, bile acid sequestrants, dopamine agonists, sodium-glucose transport protein 2 (SGLT2) inhibitors, as well as oral glucagon like peptide 1 (GLP-1) receptor agonists. He notes that oral insulin is also in development but is not yet FDA-approved.

The next time you visit your doctor, discuss your concern regarding the recall so they can help you come up with an alternative treatment plan.

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