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Metformin Lawsuit

Metformin Lawsuit

Experts are demanding recalls for the diabetes drug metformin after tests found high levels of a cancer-causing chemical called NDMA.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting metformin induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: Valisure Pharmacy Demands Metformin Recalls for High Levels of NDMA Contamination

In March 2020, the online pharmacy Valisure recommended that the FDA recall 16 batches of metformin made by 11 different companies due to excessive levels of NDMA contamination. Several batches had over 10X the daily intake limit for NDMA. The highest amount of NDMA was found in a batch of metformin made by Amneal Pharmaceuticals LLC, which contained 16.5X the daily limit of NDMA. Valisure said there was significant variability from batch to batch, even from the same company.

Valisure’s Tests Find NDMA in Metformin — FDA’s Tests Did Not

It is not clear why Valisure’s tests on metformin found high levels of NDMA when the FDA’s tests found no NDMA or extremely low levels. Valisure tested far more batches of metformin than the FDA and used a more accurate testing method. Valisure tested 38 batches made by 22 companies, with 42% testing positive for levels of NDMA above the FDA’s daily acceptable intake limit of 96-ng per day. The FDA only tested 16 batches of metformin from 7 companies.

Are There Cancer-Causing Chemicals in Metformin?

After 3 batches of metformin were recalled in Singapore in 2019, the FDA began investigating whether metformin in the U.S. contained the same carcinogen (NDMA) that led to dozens of recalls for blood-pressure drugs (valsartan) and heartburn medications (Zantac). In Febraury 2020, FDA said its tests did not find excessive levels of NDMA — but their results are being questioned.

FDA Find No NDMA or Very Low Levels in Metformin

On February 3, 2020, the FDA issued a statement to report that extensive laboratory tests on metformin did not find high levels of n-nitrosodimethylamine (NDMA). The tests found either no detectable levels of NDMA, or levels that were too low to require a recall: “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.”

FDA Investigating Cancer-Causing Toxins in Metformin

In December 2019, the FDA issued a Safety Alert after metformin was recalled in other countries due to NDMA contamination. The FDA is investigating whether metformin sold in the U.S. contains NDMA, and if it does, whether it is above their acceptable daily limit. If so, the FDA said it will recommend recalls.

What is NDMA?

N-Nitrosodimethylamine (NDMA) and similar chemicals, known collectively as nitrosamines, are toxic chemicals that are known to cause cancer in humans. NDMA is a common contaminant in water and some foods, such as grilled meat, dairy products, and vegetables.

Cancer Risk is Especially Serious for “Lifetime” Drugs Like Metformin

Unfortunately, NDMA contamination is especially concerning for a diabetes drug like metformin, because patients must take multiple pills of metformin every day for the rest of their lives. Exposure to carcinogenic chemicals every day for decades could significantly increase a person’s risk of developing cancer.

What Types of Cancer Does NDMA Cause?

  • Liver cancer
  • Kidney cancer
  • Intestinal cancer
  • Stomach cancer
  • Pancreatic cancer
  • Colon cancer
  • Esophageal cancer
  • Ovarian cancer
  • Testicular cancer
  • Bladder cancer
  • And more

Metformin Recalls in Singapore

Metformin has not been recalled in the U.S. However, outside the U.S., 3 types of metformin were recalled in Singapore after tests found unacceptable levels of NDMA.

Metformin Recalls in Canada

In February 2020, multiple metformin recalls were issued in Canada due to NDMA contamination above the daily acceptable limit. On February 5, Apotex recalled certain lots of Metformin ER (extended release) 500 mg tablets in Canada. On February 26, Ranbaxy Pharmaceuticals recalled 6 lots of metformin from the Canadian market.

After Recalls, Multiple Countries Test Metformin for NDMA

Investigations are currently underway in the U.S., Canada, the European Union and the U.K. to determine if metformin sold in those countries also contains NDMA.

What is Metformin?

Metformin is the 4th-most-commonly prescribed drug in the U.S., with approximately 80 million prescriptions written in 2019. It is a prescription drug that is used to control high blood-sugar levels in people with type-2 diabetes. Metformin is a generic medication that is sold under the names Fortamet, Glucophage, Glumetza, and Riomet.

Metformin Lawsuits

If metformin is found to be contaminated by toxic levels of NDMA, it is possible that lawsuits will be filed by people who developed cancer. Hundreds of lawsuits have already been filed by people with cancer who used valsartan or Zantac after they were recalled.

Can I Join a Class Action?

Instead of a class action lawsuit, many NDMA lawsuits have been consolidated into a Multi-District Litigation (MDL). Our lawyers are currently investigating cases involving people who took metformin and developed cancer. If you decide to file a lawsuit, we may be able to help you seek compensation for your injury, medical bills, and more.

Do I have a Metformin Lawsuit?

The Schmidt Firm, PLLC is currently accepting metformin induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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