A new recall of extended-release metformin has been announced by the U.S. Food and Drug Administration (FDA) due to concerns about a potentially cancer-causing chemical — with some health experts asking if manufacturing processes need to be improved to avoid such recalls in the first place.
The new recall, announced on December 28, 2021, affects 33 lots of metformin extended-release tablets, 750 milligrams, distributed by Viona Pharmaceuticals Inc. As with all recent recalls of extended-release metformin — stretching back to 2019 — the latest recall is based on “out-of-expectation” levels of a chemical called N-nitrosodimethylamine (NDMA). NDMA is classified a “probable human carcinogen” based on laboratory tests showing it has the potential to cause growth of cancer cells. There is no indication that the levels of NDMA found in recalled batches of metformin have any immediate health effects, and the recalls are not based on any reported adverse events. Instead, they are simply a precautionary measure to avoid the possibility of future cancer cases due to NDMA exposure.
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But even though there are no immediate health concerns related to NDMA in metformin, some health experts are pointing out that these recalls should be, and can be, avoided through better manufacturing practices. A recent article in Forbes by Bruce Y. Lee, MD, a professor of health policy and management at the City University of New York (CUNY) School of Public Health, points out that when contaminants like NDMA make their way into pharmaceuticals, it’s usually due to sloppy manufacturing practices. NDMA has also been found in heartburn and blood pressure medications in recent years, prompting recalls of those drugs, as well. Dr. Lee writes that as pharmaceutical companies try to find ways to reduce costs in the manufacturing process — something that’s especially true for generic drugs like metformin, which is manufactured around the world — the safety and purity of these drugs may suffer. There may be a need for the FDA to better monitor drug manufacturing processes — even in other countries — to ensure that drugs sold in the United States are safe and effective, according to Lee. But, of course, pharmaceutical companies oppose further monitoring and regulations, and greater funding for the FDA would be needed to implement them.
Single manufacturer affected by new metformin recall
The batch numbers and expiration dates of the Viona Pharmaceuticals metformin affected by the latest recall are available in the FDA’s recall announcement. No other manufacturers are affected by the current recall, so there’s no need to look up batch numbers if your metformin doesn’t carry a Viona Pharmaceuticals label, which is shown in the recall announcement. If you find out that your metformin is affected by the recall, don’t stop taking the drug. Instead, call your doctor or pharmacist to ask about the next steps — which are likely to include finding a suitable replacement from another batch of metformin, or from another manufacturer.
Viona Pharmaceuticals is also notifying affected customers by e-mail and regular mail, and arranging for the return of affected metformin to its recall processor, Eversana Life Science Services. If you have any questions about this process or about the recall in general, you can contact the recall processor as described in the FDA’s recall announcement.