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Posted On June 8, 2020 News,Product Recalls

Metformin Recalled for Cancer-Causing Contamination

What Patients Need to Know About the Recall, Their Risk, and Their Legal Rights

Metformin Cancer Lawsuit

Nearly 80 million patients in the United States take metformin to manage diabetes and other health conditions. New laboratory testing shows that some batches of this diabetes drug have been contaminated with unacceptably high levels of a carcinogen.

Is your metformin recalled? Could your diabetes medication have been the cause of your cancer? And what should you do now?

Who Takes Metformin?

Doctors have prescribed the drug to 120 million patients worldwide, according to Healthline. Users of metformin include:

  • Patients with type-2 diabetes
  • Patients with prediabetes
  • Pregnant women with gestational diabetes
  • Women with polycystic ovary syndrome (PCOS)
  • Women with fertility problems
  • Patients who gain weight while on antipsychotic medications
  • Other off-label uses

Although the FDA has only approved metformin for the treatment of type-2 diabetes, the drug is widely used off-label to treat many other conditions.

And, when a drug like metformin gets recalled due to contamination with a carcinogen, that means an even greater number of patients may have suffered harm because of it.

Which Metformin Is Recalled?

In May 2020, the FDA identified five pharmaceutical companies that produced the batches of metformin that, according to the agency’s laboratory tests, contained unacceptably high levels of NDMA.

As of early June 2020, four of those companies have initiated recalls of 28 products:

  1. Apotex, which recalled all lots of its metformin products with the NDC (National Drug Code) identification number 60505-0260-1
  2. Actavis Generics (part of Teva Pharmaceuticals), which recalled 14 items with various NDC and lot numbers
  3. Amneal Pharmaceuticals, which recalled all lots of 12 metformin products with various NDC numbers
  4. Time-Cap Labs, Inc. (part of Marksans Pharma), which recalled just 1 lot of metformin (lot number XP9004)

Not all metformin has been recalled. Only extended-release, not immediate-release, metformin was recalled, and only certain batches and lots made by certain manufacturers.

What’s the Risk?

The reason these metformin medications are being recalled is because they have been found to contain an impurity known as NDMA.

NDMA is a known animal carcinogen and a probable human carcinogen. There’s a great deal of research to back up its reputation for causing numerous kinds of cancer.

NDMA is dangerous, yet common. It’s found in the air, the soil, the water, and many consumer products, from the food we eat to the detergents we use for cleaning. Because exposure to very small amounts of NDMA is unavoidable, the FDA has set a maximum “reasonably safe” daily intake amount of 0.096 micrograms, or 96 nanograms.

What this means is that consuming or more than this tiny billionth of a gram on a daily basis could raise your risk for cancer. According to online pharmacy Valisure, which conducted independent laboratory testing of metformin, several of the affected batches of metformin contained more than 10 times that amount. The medication that performed the worst in testing for NDMA had 16 times that “reasonably safe” amount.

Now imagine ingesting 16 times what’s recommended as the maximum exposure – on top of whatever other environmental or dietary exposure you might have – every single day, for years, decades, even a lifetime.

The cancer-causing impact of NDMA is believed to be cumulative. It’s easy to see how a patient exposed to the carcinogen by their diabetes medication could continue unknowingly stacking their cancer risk higher and higher as the years pass.

What Kinds of Cancer Are Linked to NDMA?

The combination of numerous laboratory research on animal subjects and years of observational studies of humans who have been exposed to NDMA shows that the chemical can cause or contribute to developing numerous kinds of cancer.

Some of the cancers most closely related to NDMA contamination include:

  • Liver cancer
  • Pancreatic cancer
  • Kidney cancer
  • Bladder cancer
  • Stomach cancer
  • Intestinal cancer (small and large)
  • Colorectal cancer (colon cancer and rectum cancer)
  • Esophageal cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Prostate cancer
  • Testicular cancer
  • Ovarian cancer

How Do I Know If NMDA Caused My Cancer?

Cancer is, unfortunately, a medical event that happens all too often without an obvious cause. To determine if it’s likely that NDMA what caused you to develop cancer, a metformin injury lawsuit attorney may explore questions like:

  • How long have you been taking metformin? At what dose?
  • When were you diagnosed with cancer?
  • In general, is the type of cancer you developed common or rare? What about for patients in your age group specifically?
  • What risk factors did you already have for the type of cancer you developed?
  • What stage was your cancer? Has it seemed to progress more quickly than is normal?
  • Has a doctor suggested that there may be a link between the medication you took and your cancer? What might a medical expert think?

Generally, if you used metformin for a while before developing cancer and developed a rare cancer for which you didn’t have risk factors, there’s a strong chance that NDMA from your diabetes medication could be to blame.

What Should I Do Now?

  1. Call your doctor. If you’re currently taking a recalled batch of metformin, reach out to your doctor. Don’t stop taking the drug without first speaking to a medical professional, but make sure you discuss the risks and your options with your physician promptly.
  2. Contact and attorney. If you’ve been diagnosed with cancer, or lost to cancer a loved one who took metformin, your next step should be to reach out to an attorney. Let our metformin cancer lawyers answer your questions during a free case evaluation. Call us at 866-778-5500, we’re here to help.