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Ascend Pharmaceutical is facing a metformin lawsuit that seeks compensation for consumers who purchased allegedly worthless diabetes drugs.
According to a class action complaint filed in the U.S. District Court, District of New Jersey, on April 15th, Ascend’s metformin tablets were among those found to contain excessive levels of Nitrodimethylamine (NDMA) by Valisure, an online pharmacy that routinely batch tests the medications it sells. (Case 2:20-cv-04329)
NDMA is an environmental contaminant that frequently forms as a byproduct of certain manufacturing processes. The compound is designated a “probable human carcinogen” by the U.S. Environmental Protection Agency based on animal experiments that suggest exposure may increase the risk of cancer, including tumors of the kidneys, gastrointestinal tract, and liver.
The U.S. Food & Drug Administration (FDA) has established a strict daily intake limit of 96 nanograms for NDMA. But according to the class action lawsuit, Valisure’s tests indicated that metformin tablets marketed by Amneal contained 11-times that amount. Despite the pharmacy’s recommendation that the affected lots be recalled, Amneal has yet to take any action and continues to market its metformin as safe and effective for its intended use.
“Plaintiff and the Class were injured by the full purchase price of their metformin medications. These medications are worthless, as they contain harmful levels of NDMA,” the complaint states. “As the medications expose users to NDMA well above the legal limit, the medications are not fit for human consumption. Plaintiff is further entitled to statutory damages, damages for the injury sustained in consuming high levels of acutely toxic NDMA, and for damages related to Defendant’s conduct.”
Metformin is the most widely prescribed oral treatment for Type 2 diabetes. The presence of NDMA – especially at such high levels – is particularly concerning, since metformin must be taken daily.
Late last year, the discovery of NDMA in some tablets prompted regulators in Singapore to recall six metformin lots. Similar metformin recalls have since been announced in Canada.
The FDA launched its own investigation in response to the Singapore recalls. While the agency’s tests did find NDMA in some samples, the levels detected were far below 96 nanograms. As a result, the FDA did not order any metformin recalls in the United States.
In March, however, Valisure announced that its own investigation had detected exessive levels of NDMA in 16 of 38 metformin samples tested. The highest amounts were found in Amneal Pharmaceutical’s metformin, which in some cases contained as much as 16-times the FDA’s recommended daily limits. Several companies’ metformin contained more than 10 times the limit.
Valisure has since petitioned the FDA for a metformin recall and requested that the agency investigate how NDMA came to contaminate the medications.