According to a proposed class action lawsuit, generic metformin manufactured by Heritage Pharmaceuticals, Inc. has been found to contain dangerously high levels of probable carcinogen N-nitrosodimethylamine (NDMA).
The complaint out of New Jersey states that online pharmacy Valisure announced on March 2, 2020 that it had detected high levels of NDMA in prescription metformin, a drug sometimes sold under the brand name Glucophage that’s used to control high blood sugar in patients with type 2 diabetes. According to the case, NDMA, which Valisure said was found in batches manufactured by Heritage, doing business as Avet Pharmaceuticals, was formerly used in the production of liquid rocket fuel and has been linked to liver damage and cancer in humans.
The lawsuit claims the defendant’s metformin was found to contain between 5.3 and nearly nine times the FDA’s daily intake limit for NDMA, which the case notes is “particularly troubling” given the medication is to be taken daily.
According to Valisure, the contamination may be linked to problems in the manufacturing process rather than “a fundamental instability of the drug molecule,” the case says. The lawsuit argues that Avet’s metformin medications would not be contaminated with NDMA if the drug had been “properly manufactured.”
Although Valisure recommended a recall of Avet’s metformin medications, the lawsuit claims the company has not only refused to pull the drug from the market but continues to tout on its website that it manufactures “high quality generic medicines.” The suit argues that the defendant’s customers have been, and continue to be, misled by Avet’s representations that its metformin is “safe and effective.”
“However, these representations are false,” the complaint scathes, “as Defendant’s metformin medication contains the carcinogenic impurity NDMA.”
The suit claims proposed class members would not have purchased the medication, or would have paid less for the drug, had they known Avet’s metformin was contaminated with “dangerously high levels” of NDMA.