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The makers of generic versions of metformin face a growing number of class action lawsuits, following allegations that some batches contain high levels of the cancer-causing chemical byproduct N-nitrosodimethylamine (NDMA), which has been linked to reports of stomach cancer, colorectal cancer and other injuries after contaminating other drugs.
In recent days, at least two new class action claims have been filed. One complaint (PDF) was filed by Jacqueline Harris in New Jersey federal court on March 27, and the other compaint (PDF) was filed by Michael Hann on March 30 in the same court.
Both see class action status for all consumers who purchased metformin contaminated with NDMA. According to the complaints, the drug makers named as defendants misrepresented the safety of metformin for years, and knew or should have known about the presence of NDMA. Harris’s lawsuit names Aurobindo, Aurolife Pharma, Heritage Pharmaceuticals, Emcure Pharmaceuticals, Rite-Aid Corporation and potentially dozens of unnamed parties as defendants. Hann’s lawsuit names Heritage Pharmaceuticals as the defendant.
NDMA is a chemical byproduct considered a carcinogen. In recent months, detection of the chemical in other drugs has resulted in wide scale Zantac recalls and valsartan recalls, after it was confirmed that dangerously high levels of NDMA were present in the popular heartburn and blood pressure medications.
Late last year, reports first warned about the potential risk of metformin NDMA contamination problems, after some versions of the drug sold outside the United States tested positive for the chemical, raising concerns that metformin recalls may be necessary. However, the FDA indicated at that time that testing of products distributed in the U.S. found that the NDMA levels in metformin were undetectable or below federal limits for exposure to the chemical.
Earlier this month, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to issue metformin recalls, after independent testing found levels of NDMA in certain pills that was higher than the agency’s recommended daily exposure threshold of 96 nanograms.
Metformin is sold by a number of different generic drug makers, and also marketed under several brand names, including Glucophage, Carbophage, Fortamet, Diabex and Riomet. It is also often used in combination with other diabetes drugs.
“At all times during the period alleged herein, Defendants represented and warranted to consumers that their generic Metformin products were otherwise fit for their ordinary uses, and were otherwise manufactured and distributed in accordance with applicable laws and regulations,” Harris’s lawsuit states. “However, for years, Defendants willfully flouted federal current Good Manufacturing Practices and ignored other warnings signs that Defendants’ Metformin products contained or likely contained NDMA and/or other impurities.”
NDMA In Zantac and Valsartan
Valisure is the same pharmacy which first raised alarms about the link between Zantac and cancer in September 2019, after finding that some pills contained 3,000,000 ng of NDMA. This led to further FDA testing, which confirmed the high levels were present in virtually all Zantac products and their generic equivalents, resulting in a widespread, and still ongoing, Zantac recall.
Concerns over NDMA drug contamination in pharmaceutical drugs began to emerge in 2018, with an investigation into a number of generic blood pressure drugs that were found to contain high levels of the chemical. This led to several rounds of recalls for valsartan, losartan and irbesartan, and investigations suggested that NDMC may have contaminated the drugs as a by-product of changes in the generic drug manufacturing process.
In response to concerns about the cancer risk with valsartan and other similar drugs, and the possibility of shortages for the hypertension drugs, the FDA established a permissible daily limit for NDMA at 96 nanograms, requiring pills that may expose users to more of the carcinogen to be recalled.
While drug makers and federal regulators indicate they are continuing to investigate the underlying cause of both the NDMA contamination, many consumers diagnosed with cancer in recent years are now pursuing valsartan lawsuits and Zantac lawsuits, alleging they may have avoided a cancer diagnosis if other treatments had been used.