There has been a recall of the widely-prescribed diabetes medication metformin by at least one drug maker due to high levels of a cancer-causing agent known as N-Nitrosodimethylamine (NDMA). The U.S. Food and Drug Administration (FDA) stated that it is in contact with five pharmaceutical manufacturers about recalling their extended-release versions of the popular diabetes drug. Laboratory tests conducted by the FDA have shown alarmingly high levels of NDMA in several batches of the extended-release (E.R.) version of metformin, which is used to control blood glucose in Type 2 diabetics.
Metformin E.R. recalls over cancer risk
On June 1, 2020, the Canadian pharmaceutical corporation Apotex announced a voluntary recall for all lots of 500 mg metformin hydrochloride extended-release tablets, which FDA tests revealed had higher than acceptable levels of the potential carcinogen.
U.S. health regulators began investigating metformin this past December after some formulations available in other countries tested positive for NDMA contamination. According to Bloomberg, metformin is the third most widely used medication in recent years to be recalled due to the cancer risks of NDMA.
The agency stated that elevated NDMA levels were only discovered in extended-release formulations of the diabetes drug, and no risks were observed with immediate-release metformin. Last March, the online pharmacy Valisure, which conducts independent tests on all of its products, found NDMA above acceptable limits in metformin capsules made by Aurobindo Pharma Ltd, Amneal Pharmaceuticals, Lupin Ltd, and others. The online pharmacy did tests on both regular and extended-release metformin and urged the FDA to initiate recalls.
At present, a handful of generic drug manufacturers across the world make metformin for the U.S. market. Since the FDA’s most recent communication this May, four other drugmakers have since pulled their extended-release tablets from the market due to the detection of Nitrosodimethylamine. These include: Amneal Pharmaceuticals LLC, Marksans Pharma Limited, Teva Pharmaceuticals USA Inc. and Lupin Pharmaceuticals, Inc.
NDMA is an organic compound that occurs in both natural and industrial processes. Medical professionals state that overexposure to NDMA can cause several health complications, including fever, nausea, stomach pain, jaundice, and reduced lung and kidney function.
The chemical has been classified as a probable carcinogen by the International Agency for Research on Cancer (IARC), and there is conclusive evidence of its cancer-causing properties in animal experiments. NDMA modifies the DNA and has been shown to cause gastric or colorectal cancer in animal trials. While additional research on NDMA cancer risk in humans is needed, substantive animal studies raise valid safety concerns.
Cancer-causing drugs and legal recourse
Showard Law Firm is offering free case reviews to patients who took metformin and developed cancer. Recent recalls of the diabetes drug are encouraging but may be cold comfort to those who have already been sickened by high levels of NDMA exposure. Fortunately, there is legal recourse for cancer-causing drugs that were properly tested and pose a very real danger to the public at large. Call our law office for professional legal advice on whether you have a valid claim for damages.
- Bloomberg, FDA Found Elevated Levels Of A Carcinogen In Some Versions Of Popular Diabetes Drug https://www.bloomberg.com/news/articles/2020-05-27/fda-finds-carcinogen-in-some-versions-of-popular-diabetes-drug
- FDA, FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
- Times Now, FDA asks five firms to recall diabetes drug metformin with high levels of probable carcinogen https://www.timesnownews.com/health/article/fda-asks-five-firms-to-recall-diabetes-drug-metformin-with-high-levels-of-probable-carcinogen/598636