Metformin Lawsuits Seeking Monetary Compensation Due to Cancerous N-nitrosodimethylamine (NDMA) Contamination is Likely to Explode in 2021 and Beyond.
THE UNITED STATES – According to a news report posted on medpagetoday.com, the total number of Metformin products recalled in 2020 grew substantially. The most recent list of recalled Metformin drugs recalled totaled 254 products. In December of 2019, the U.S. Food and Drug Administration alerted the public about specific extended-release Metformin medications that were found to be contaminated with N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine is a known carcinogen to humans. The identified products were promptly recalled. However, throughout 2020, the number of Metformin medications recalled continued to escalate month after month.
Initially, the FDA’s warning only applied to certain medications, and those medications were manufactured over-seas at facilities based in China and India. However, a few months later, the FDA announced new laboratory test results did discover traces of NDMA in some domestic Metformin products tested. The FDA did not initiate action concerning domestically produced Metformin products.
In May of 2020, further tests discovered that many lots of extended-release Metformin formulations contained NDMA quantities that were deemed “higher-than-acceptable.” The FDA then prompted specific Metformin manufacturing companies to issue voluntary recalls. The May recalls affected five drug manufacturers of extended-release Metformin. The recalled extended-release Metformin brands were Apotex, Amneal, Teva (Actavis), Marksans Pharma, and Lupin. No immediate-release Metformin products have been recalled at this time.
Matt Petersen, vice president of medical information and professional engagement for the American Diabetes Association (ADA), gave an official statement concerning the Metformin recalls, “Patients should continue to take their Metformin until their pharmacist supplies a different manufacturer’s product or their doctor prescribes a different treatment. Medications should not be stopped unless directed to do so by their doctor.”
Following the American Diabetes Association’s official statement, the FDA published an announcement in the American Association of Pharmaceutical Scientists Journal, revealing the circumstances behind the reported NDMA testing discrepancies between private laboratories and the FDA. The FDA’s letter was considered a “cautionary” response since the FDA noted some discrepancies were caused by N,N-dimethylformamide (DMF) conflating levels mass spectrometry measurements during its NDMA testing.
To make matters more confusing for physicians and patients, the FDA suddenly expanded the list of Metformin medications to be recalled due to possible “high levels of NDMA.” The second round of recalls included the following Metformin manufacturers: Granules Pharmaceuticals, Lupin Pharmaceuticals (all lots), AvKARE (Amneal), PD-Rx Pharmaceuticals (Amnea and Marksans), the Harvard Drug Group (Apotex), and Preferred Pharmaceuticals (Marksans). Then in August of 2020, the FDA announced Bayshore Pharmaceuticals was added to the ever-growing list of recalled extended-release Metformin.
In early October 2020, Markson’s Pharma’s (Time-Cap Labs) extended-release metformin tablets and Sun Pharmaceutical Industries’ Metformin hydrochloride for extended-release oral suspension were both added to the recall list.
Last month, Nostrum Laboratories’ has recalled batches of its extended-release Metformin.
Currently, the FDA’s testing and analysis have not connected immediate-release Metformin with unsafe levels of NDMA contamination. This is good news since immediate-release Metformin is the most regularly prescribed form of Metformin.
To view the FDA’s most current list of recalled Metformin medications, click here.
Metformin users who have developed NDMA-related cancer or injuries may be able to file a lawsuit to recover monetary compensation.
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