Following the U.S. Food and Drug Administration’s recent findings, pharmaceutical companies have begun recalling extended-release metformin products due to NDMA contamination. Metformin is a common drug used to control blood sugar in people with type 2 diabetes and those who are insulin resistant and in danger of developing diabetes.
NDMA, also known as N-Nitrosodimethylamine, is a naturally occurring substance that is often found in trace amounts in medications as well as in water and other natural sources. In small amounts, it is not considered harmful. However, it can also be created as a byproduct of industrial processes, and if it surpasses certain levels, it may be capable of causing certain types of cancer. Large amounts of NDMA have recently been discovered in a few common blood pressure and heartburn medications, leading to concern that other drugs might carry the carcinogen as well.
Last year, the FDA announced that it would begin testing the diabetes drug metformin for high concentrations of NDMA, which could cause cancer. In April of this year, the FDA finished its testing and reported that they had not found any unsafe amounts of NDMA in any of the metformin products that they had tested (some contained low amounts of the impurity which are considered safe).
However, shortly after that, Health Canada tested Canadian metformin products and found unsafe concentrations of NDMA, prompting several recalls. Online U.S. pharmaceutical company Valisure also tested the drug and found the same. Because this evidence conflicted with the FDA’s findings, the administration began testing more metformin products, specifically extended-release drugs.
In late May, 2020, the FDA announced that it had indeed uncovered unsafe levels of NDMA in several extended-release metformin products, hailing from five different pharmaceutical companies. The organization requested that these companies voluntarily recall their products.
One of the pharmaceutical companies, Apotex, almost immediately recalled its affected medications at the retail level “out of an abundance of caution.” The recall included USP 500mg metformin hydrochloride extended-release tablets. The names of the other companies, however, were not immediately released, and it has taken more than a week for some of the new recalls to surface.
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Now, however, more recalls are beginning to surface. Apotex has expanded its recall to the consumer level, and a few other companies have jumped on the bandwagon as well. Amneal Pharmaceuticals LLC has issued a voluntary nationwide recall for the extended-release version of the drug, USP 500 mg and 750 mg. Teva Pharmaceuticals USA, Inc. has recalled 14 lots of metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg, 100- and 1,000-count bottles in the U.S. And Marksans Pharma Limited has also recalled 11,279 bottles of its metformin hydrochloride extended-release tablets, USP 500mg, lot # XP9004 with an expiration date of December 2020.
You can learn more about what to look for to find out whether your medication is being recalled and how to get a replacement here.
The FDA is currently looking into the cause of the NDMA contamination, which appears in some finished-dose tablets but not in the active metformin ingredient inside them. The FDA has also asked pharmaceutical companies to test all batches of their metformin products for similar impurities in the future.
“The FDA has strict standards for safety, effectiveness and quality, and the agency makes every effort based on science and data to help keep the U.S. drug supply safe. We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”
You can find a complete list of recalled products on the FDA’s website. At this time, we do not know whether more recalls will follow the ones that have already come out or whether the recalls will cause a shortage of metformin products in the near future.
If your medication is recalled, make arrangements with your doctor and your pharmacist to get a replacement. Please do NOT discontinue the use of your recalled medication until consulting your physician, as the risks of not taking your medication could be far worse than the very minimal risk of developing cancer from an NDMA-contaminated product. If you’re not sure whether your medication is on the recall list, please contact your doctor or pharmacist for more information.
And please share this recall information with your friends so they can do the same!Whizzco