Metformin

In this article:

• What is Metformin?
• Metformin Recalled in Other Countries and Under Review in the U.S.
• What is NDMA?
• Metformin Lawsuits
• Monetary Damages Sought in a Metformin Claim
• Metformin Wrongful Death
• Metformin’s Cancer Link
• What To Do If You Are a Metformin User
• Cancers Linked to Metformin
• An Experienced Lawyer Can Establish Drug Maker Negligence
• Drug Manufacturers are Aware of Metformin Dangers
• Seek Expert Legal Help

Metformin is a diabetes medicine that controls blood sugar levels.  The medication is taken orally by adults with Type 2 diabetes.  It is one of the most commonly prescribed medications in the United States.  In 2019, it accounted for more than 80 million prescriptions.

Some of the brand names under which metformin is marketed in the United States are:

• Glucophage
• Glucophage XR
• Glumetza
• Fortamet
• Riomet

In December 2019, certain metformin medicines were recalled by Singapore’s Health Sciences Authority because they contained amounts of N-nitrosodimethylamine (NDMA), that were above the acceptable level.

In February and March 2020, several Canadian Drug makers recalled formulations of metformin due to unacceptably high levels of NDMA.

On March 2, 2020, Connecticut-based pharmacy Valisure filed a Citizen Petition with the Food and Drug Administration (FDA).  The petition urged the FDA to recall certain lots of metformin to ensure the safety of the American drug supply. The petition included testing results showing high levels of NDMA.

To date, the FDA has not issued a recall, but one may be issued in the near future.

NDMA is an odorless liquid that was produced in the United States as a component of rocket fuel.  Production was discontinued after high levels of the substance were found in soil, air, and water samples were taken near a rocket fuel plant.  NDMA is also formed in the course of other manufacturing processes.

Conclusive evidence has been revealed through animal experiments that NDMA is a potent carcinogen.

The Agency for Toxic Substances and Disease Registry (ATSDR), which is part of the U.S. Department of Health and Human Services, states that it is reasonable to expect that NDMA exposure via drinking, eating, or breathing, could cause cancer in humans.

The findings of unacceptably high levels of carcinogen NDMA in formulations of metformin are very concerning to people who have used and are currently using metformin.  If, after taking metformin, you have been diagnosed with cancer, you understandably will have questions about pursuing legal action against the negligent drug manufacturers.

Benefits of filing a personal injury claim for disease caused by metformin

• Monetary compensation paid for the physical harm or disease caused by your use of metformin.
• Economic recovery for the pain and suffering caused by your physical harm or disease, including the effects it has had on your marital relationship, if applicable.
• Dangerous drug manufacturers, distributors, and marketers should be held responsible for profiting off of their hazardous products.
• Save future lives: Lawsuits filed against dangerous drug manufacturers can help ensure more stringent testing so that future drugs marketed toward consumers are safe.
• Lawsuits against dangerous drug manufacturers have resulted in new laws being passed that help protect future consumers.

Monetary damages in a metformin lawsuit will be dependent upon several factors, including the severity of the physical harm that was caused by the drug.

Factors to consider in a Metformin lawsuit:

• What is the health condition(s) that resulted from metformin use?
• What effect does the metformin-caused health condition have on the injured person’s quality of life and the quality of life of his or her spouse?
• Did the metformin-caused health condition have negative effects on the injured person’s financial life and ability to earn money, both presently and in the future?

A wrongful death lawsuit is a personal injury case that is filed on behalf of a person who died from a health condition caused by metformin use.  A wrongful death suit is filed by the deceased person’s heirs.

U.S. pharmacy Valisure tested and detected high levels of NDMA in certain lots of metformin.  They filed a Citizen Petition with the FDA on March 2, 2020, in which they requested an FDA recall of those lots.

Valisure tested metformin drugs from 22 companies. They tested 38 batches of the medication.  From that testing, 16 batches were found to have NDMA levels above the acceptable daily intake of 96 nanograms (ng). Those batches came from 11 of the 22 companies.  Several of the batches were found to have more than 10 times the acceptable daily limit.

Valisure’s petition pointed out that multiple metformin tablets can be taken daily over a user's lifetime, making the presence of high levels of NDMA especially concerning and underscoring the need for swift action to protect users - especially given that diabetes is increasingly common among young adults and even adolescents.

Metformin is a prescription drug in the United States.  Users of the drug should not stop taking it without consulting their doctor.  If you are currently taking the medication and are concerned about the test findings, you can contact your prescribing physician to discuss treatment alternatives.

The carcinogenic chemical NDMA has been found in recent tests to be present in unacceptably high levels in certain metformin drugs.  The types of cancer that have been linked to NDMA, and therefore to metformin include but may not be limited to:

• Primary liver cancer
• Primary prostate cancer
• Primary bladder cancer
• Primary bile duct cancer
• Primary colorectal cancer
• Primary stomach cancer
• Primary kidney cancer
• Pancreatic cancer

For a personal injury claim against a drug manufacturer to be successful, negligence on the part of the manufacturer must be established.  The makers of metformin are negligent if they fail to warn patients of the known cancer risks associated with its use.  Drugmakers have a duty to protect users of their products. If the drugmaker fails in its duty to protect, and as a result, a user is harmed by the use of a medication, negligence can be established.

Currently, the FDA has not issued a recall of metformin products, but that does not mean that manufacturers are not aware of the danger.  As noted above, other countries have recalled metformin products as far back as 2019, and as of March 2, 2020, there is a Citizen Petition on file with the United States FDA that requests a recall.  Valisure's petition references its test results that found unsafe levels of NDMA.

Since the 1960s, the carcinogenic nature of NDMA has been studied extensively by the scientific community. NDMA is classified by the International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) as a probable human carcinogen.  The FDA has set strict daily limits of NDMA because it recognizes the danger of the substance.

Below is a news clip reporting on an FDA investigation into NDMA in metformin.

There are many complicated layers associated with a dangerous drug manufacturer lawsuit.  Pharmaceutical companies have bottomless pockets and will vigorously defend their case to protect their enormous profits.  If you or someone you love has been diagnosed with cancer after taking metformin, you must hire a lawyer with extensive experience in drug manufacturer litigation.

If you or a member of your family has been diagnosed with a severe condition after taking Metformin, call our law office to get free, friendly advice. We can be reached at (916) 921-6400 or (800) 404-5400. You can also contact us online.

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DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer/Services Agreement. No attorney-client relationship will exist between you and our firm unless and until we enter into a signed Retainer/Services Agreement. The information you obtain at this site is not, nor is it intended to be medical or legal advice. Do not stop taking any medication without consulting your physician.

^{Photo: Ajale on Pixabay :mm llo [cs 1342] Editor’s Note: updated for accuracy and relevancy [cha 7.7.23]}