A California man has filed a proposed class action lawsuit against the manufacturers of generic metformin, a first-line diabetes treatment, after learning the drug contains “dangerously high levels” of a probable human carcinogen.

Michael Hann filed the lawsuit in New Jersey federal court against New Jersey-based Heritage Pharmaceuticals, doing business as Avet Pharmaceuticals Inc., claiming he was injured after consuming the company’s tainted metformin. Hann said he learned that the drug was contaminated with the probable cancer-causing impurity known as NDMA from the news.

In December, both the Food and Drug Administration (FDA) and Health Canada alerted consumers that NDMA was discovered in some metformin drugs by online pharmacy Valisure. Both agencies launched investigations. Shortly thereafter, Health Canada issued three back-to-back recalls of metformin products from different manufacturers. In February, the FDA said that it was not recalling any metformin products at that time because the agency did not find that the NDMA in the drugs exceeded the acceptable daily intake.

On March 2, Valisure petitioned the FDA to recall various metformin products after detecting high levels of NDMA in “specific batches of prescription drug products containing metformin,” including those made by Avet. The pharmacy said “the presence of NDMA … may be primarily due to contamination during manufacturing as opposed to fundamental instability of the drug molecule.”

In 2018, NDMA was found in several medications known as angiotensin II receptor blockers, or ARBs, used to treat high blood pressure and heart failure. The discovery, linked to contamination during manufacturing, led to recalls of numerous ARB drugs.

In September, Valisure alerted health authorities that it had discovered NDMA in various brands and generic versions of ranitidine, the active ingredient in the brand-name heartburn drug Zantac. Ranitidine was found to cause NDMA to form in the body after ingestion. The findings led to dozens of recalls of both over-the-counter and prescription versions of ranitidine.

Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us. We are not reviewing claims related to metformin at this time.

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