As we noted recently, one of the many detestable titles that the year 2020 earned is year of metformin recalls. Starting in late 2019, actually, the U.S. Food and Drug Administration (FDA) announced that it was investigating reports of possible contamination in metformin products sold in foreign countries, and whether these concerns might apply to formulations of the drug sold in the United States.
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Metformin is considered the first-line drug for treating type 2 diabetes, and is one of the most popular drugs in the world. It’s a generic medicine that’s produced by many manufacturers, in many different doses and formulations. When it comes to potential recalls, this multitude of manufacturers is both good and bad — good since it means that any recall wouldn’t affect the entire supply of a drug, and bad since it means testing numerous batches of drugs from different sources when there are any safety concerns.
Now, the first metformin recall of 2021 seems to fit the last year’s pattern of recalls.
Unacceptable levels of impurities
The latest recall, announced on the FDA website, concerns a batch manufactured by Nostrum Laboratories, Inc., based in Somerset, New Jersey. Labeled as Metformin HCl Extended Release Tablets, USP 750 mg, these pills were found to contain N-nitrosodimethylamine, or NDMA — a potentially cancer-causing impurity that can result from drug manufacturing processes — at levels higher than the FDA’s limit of 96 nanograms per day.
According to the press release, NDMA is considered a “probable human carcinogen” based on laboratory tests. It’s very difficult to prove that a substance causes cancer in real-world situations, due to the difficulty of tracking a person’s exposure to the substance and ruling out other causes of cancer — not to mention the long stretches of time during which this would need to happen. NDMA is a known environmental contaminant, and has been found in water and foods, including meat, dairy products and vegetables.
The latest metformin recall is voluntary, and no adverse events have been reported by anyone taking the drug. The concern regarding NDMA is that long-term use of the drug could increase the risk of cancer, so no immediate adverse events would have been expected due to the drug’s contamination. The recalled batch has a lot number of MET200501, with an expiration date of July 2022.
Keep taking metformin as prescribed
If you happen to be in possession of pills from the recalled batch of metformin, you should continue to take them as prescribed while you contact your pharmacist or doctor about finding a suitable replacement. Your pharmacist may be able to simply switch you to a different version of extended-release metformin at the same dose. Otherwise, your doctor may need to prescribe you a different version of metformin to take.
While you should contact your doctor to discuss any health concerns you believe are related to taking the recalled product, it’s unlikely that there would be any immediate or short-term health problems caused by exposure to elevated levels of NDMA.
The FDA maintains a searchable list of all recently recalled metformin products, which contained 254 products with varying formulations, doses and packaging before the latest announcement.