Experts are demanding recalls for the diabetes drug metformin after tests found high levels of a toxic cancer-causing chemical called NDMA.
Need a Texas Metformin Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with cancer, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: Pharmacy Finds High Levels of NDMA, Demands Metformin Recalls
In March 2020, the online pharmacy Valisure petitioned the FDA to recall metformin after 16 batches made by 11 companies tested positive for high levels of a cancer-causing chemical called NDMA.
Valisure warned that many batches of metformin had over 10X the FDA’s daily intake limit for NDMA, and one batch of metformin made Amneal Pharmaceuticals LLC had 16.5X the daily limit of NDMA.
FDA’s Tests Found No NDMA in Metformin, Valisure’s Did — Who Is Right?
Valisure’s tests found highly-variable levels of NDMA from batch to batch, even from the same company, which may help explain why the FDA’s tests found no NDMA or only extremely low levels.
Valisure said it is not clear why their tests found high levels of NDMA in metformin, when the FDA did not. Valisure said it used a more accurate testing method than the FDA. Valisure also tested more batches. Valisure tested 38 batches of metformin made by 22 companies, and 42% tested positive for high levels of NDMA. The FDA only tested 16 batches of metformin from 7 drug-makers.
FDA Metformin Tests Find No NDMA or Very Low Levels
On February 3, 2020, the FDA issued a statement after laboratory tests on metformin detected extremely low levels of n-nitrosodimethylamine (NDMA), or no NDMA was detected at all: “To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.”
What is the problem?
Health agencies in the U.S., Canada and Europe are investigating whether the type-2 diabetes drug metformin contains the same cancer-causing chemical that led to global recalls for blood pressure drugs (valsartan) and heartburn medications (Zantac) in early 2019.
Metformin May Be Contaminated With Cancer-Causing Toxin
In December 2019, the FDA opened an investigation into possible NDMA contamination in metformin sold in the U.S., after recalls were issued in other countries, and similar investigations were launched in Europe.
If tests on metformin in the U.S. find NDMA above the acceptable daily limit of 96 micrograms, the FDA said it will recommend recalls.
What is NDMA?
N-Nitrosodimethylamine (NDMA) and similar chemicals, collectively called nitrosamines, are known carcinogens (cancer-causing substances). Everyone is exposed to some level of NDMA because it is commonly found in water and foods like grilled meat, dairy products, and vegetables.
List of Cancers Linked to NDMA
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Esophageal cancer
- Ovarian cancer
- Testicular cancer
- Bladder cancer
- And more
Metformin has not been recalled in the U.S. yet, but Valisure petitioned the FDA to issue recalls in February 2020. Certain batches of metformin have been recalled in Singapore and Canada.
In December 2019, Singapore recalled 3 batches of metformin after finding unacceptable levels of NDMA.
In February 2020, Canada issued multiple recalls for metformin after tests found high levels of NDMA: On February 24, six batches of metformin were recalled by Ranbaxy Pharmaceuticals. On February 5, eight batches of Metformin-ER (extended release) 500-mg tablets were recalled by Apotex Inc.
What is Metformin?
Metformin is the 4th most commonly prescribed drug in the U.S., with 80 million prescriptions written in 2019 alone. It is used to help people with type-2 diabetes control their blood-sugar levels. Metformin is a generic drug that is also sold under the names Fortamet, Glucophage, Glumetza, and Riomet.
If metformin is recalled in the U.S. due to NDMA, it is possible that people with cancer will be able to file lawsuits and seek compensation for their injury, medical expenses, wrongful death of a loved one, and more. Over 150 lawsuits were filed after Valsartan, Zantac, and other medications were recalled due to NDMA.
Is There a Metformin Class Action?
Instead of a class action lawsuit, our lawyers are investigating individual metformin lawsuits for people who developed cancer.
Lawsuits involving NDMA contamination are not part of a class action. Instead, in the case of valsartan, the lawsuits are centralized in a Multi-District Litigation (MDL).
Need a Metformin Lawyer in Texas?
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