Excessive levels of NDMA prompt Recalls of Metformin

Metformin, a drug frequently prescribed to patients with type 2 diabetes to manage blood glucose levels, is one of the most commonly prescribed drugs in the United States. More than 78 million prescriptions for Metformin were written in 2017, according to the Agency for Healthcare Research and Quality, with the extended-release version of the drug accounting for about one-quarter of those prescriptions.


What prompted Recalls of Metformin in the United States?

The US Food and Drug Administration announced it had become aware of NDMA in some metformin products in other countries in late 2019. Following that discovery, the agency began testing immediately to determine whether the supply of Metformin within the United States was at risk as well, as part of the ongoing investigation into nitrosamine impurities across medication types.

In a May 28, 2020 press release from the US Food and Drug Administration (FDA), it was noted that agency laboratories discovered levels of NDMA in several lots of Metformin extended-release products that exceeded the nation’s acceptable intake limits.

Following their discovery, FDA officials asked the following five pharmaceutical companies to voluntarily recall their extended-release (ER) formulations of Metformin Hydrochloride:

  • Actavis Pharma Inc.,

  • Amneal Pharmaceuticals, LLC,

  • Apotex Corp.,

  • Lupin Pharma and

  • Marksans Pharma Ltd.


All manufacturers of metformin-containing ER products are being asked to evaluate the risk of excessive NDMA in their products and to test each batch before releasing it into the U.S. market. If levels of NDMA are found to be above the acceptable intake limit, the manufacturer should inform the Food and Drug Administration, and halt its release immediately.

The first voluntary recall comes from Teva Pharmaceuticals USA. The company is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the acceptable daily intake limit.

What is N-nitrosodimethylamine?

N-nitrosodimethylamine (NDMA) can be produced naturally and artificially, and was formerly used in the production of rocket fuel, lubricant additives, and plastics. It is a type of N-nitrosamine, a family of chemicals that are known carcinogens. It is not currently produced or commercially used in the US, except for in laboratory research. In fact, its main use today is to induce tumor growth in experimental animals, and it has been known as a cancer risk for decades. It is classified as a probable carcinogen by the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), World Health Organization (WHO), and the International Agency for Research on Cancer (IARC).

There are multiple reasons for the presence of NDMA in drugs. The FDA has previously found that the source of NDMA can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged.

NDMA Human Epidemiological Studies

There have been several human epidemiological studies that have found a link between various forms of cancers and N-nitrosodimethylamine exposure:

A case-control study in 1995 investigated NDMA dietary exposure with 220 cases found a statistically significant 700% increased risk of gastric cancer in persons exposed to more than 0.51 ng/day.

A case-control study in 1995 investigated NDMA dietary exposure with 746 cases found statistically significant elevated rates of gastric cancer in persons exposed to more than 0.191 ng/day.

A case-control study in 1995, looked at, in part, the effects of dietary consumption on cancer, found a statistically significant elevated risk of developing aerodigestive (respiratory and digestive tracts) cancer after being exposed to NDMA at .179 ng/day.

A cohort study in 1999 examined NDMA dietary exposure with 189 cases and a follow up of 24 years found that “N-nitroso compounds are potent carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing colorectal cancer.

A cohort study in 2000 looked at occupational exposure of workers in the rubber industry observed significantly increased risks for NDMA exposure for cancer of the brain, esophagus, oral cavity, pharynx, and prostate.

A cohort study in 2011 investigated NDMA dietary exposure with 3,268 cases and a follow up of 11.4 years concluded that “[d]ietary NDMA intake was significantly associated with increased cancer risk in men and women” for all cancers, and that “NDMA was associated with increased risk of gastrointestinal cancers,” including rectal cancers.

A case-control study in 2014 looked at NDMA dietary exposure with 2,481 cases found a statistically significant elevated association between NDMA and colorectal cancer.

What does this recall mean for those patients who have been prescribed Metformin Extended-Release products?

NDMA has been found to cause an increased risk of developing the following cancers:

  • Bladder cancer

  • Breast cancer

  • Esophageal cancer

  • Intestinal cancer

  • Kidney cancer

  • Liver cancer

  • Lung cancer (for non-smokers)

  • Ovarian cancer

  • Pancreatic cancer

  • Prostate cancer

  • Stomach cancer

  • Testicular cancer

  • Thyroid cancer

  • Uterine cancer

Currently, the FDA is recommending that physicians continue to prescribe metformin when clinically appropriate. In addition, the agency recommends that patients do not stop taking metformin products until they consult with their physician for an adequate and approved treatment replacement, even after any recalls occur.

How can Kwartler Manus, LLC. Help?

Metformin, marketed under the trade name Glucophage, was first introduced to the U.S. market in 1995 and became one of the most prescribed drugs in its category, there have been many people taking it for many years. If you or a loved one has developed cancer after using Metformin, you aren’t alone. Our dedicated attorneys have experience representing clients in mass tort cases (when a civil wrong is committed by a person, entity, or group which results in injury to many victims).

By filing/joining a mass tort claim against Metformin, you may be able to get compensation for your damages and protect others from future threats. Our attorneys will be by your side to help you navigate this complex process with ease.

Don’t hesitate to pursue the compensation you deserve to make up for these pharmaceutical companies’ mistakes. Contact us online today or by phone at (267) 214-8608 to schedule a free consultation and learn your rights.

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