Over the past year, world regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have uncovered, investigated, and recalled medications due to nitrosamine impurities such as NDMA. In 2018, many of the blood pressure ‘sartan’ medications (angiotensin II receptor blockers known as ARBs), including Valsartan and Losartan, were recalled due to NDMA contamination. In 2019 and 2020, various companies have issued voluntary recalls of popular heartburn medication Zantac and other ranitidine products after uncovering NDMA contamination.
In December 2019, the global investigations of NDMA impurities extended to the type-2 diabetes drug Metformin after the public health agency of Singapore recalled three out of the 46 locally marketed Metformin medications due to the presence of NDMA.
Singapore Metformin Recalls
Singapore’s Health Sciences Authority (HSA) tested all 46 locally distributed Metformin medicines and three were found to have trace amounts of NDMA which were “above the internationally accepted level.”
As a result, on December 4, 2019 the HSA recalled the three medicines as a “precautionary measure” but also announced that the other 43 Metformin medications were not contaminated.
Which Metformin Medications were Recalled in Singapore?
- One batch of Glucient XR Tablet 500mg—supplied by Glorious Dexa Singapore
- All batches of Meijumet Prolonged Release Tablet in 750mg and 1000mg –supplied by Pharmazen Medical
Singapore’s HSA claims that the risk to patients who have been taking the affected medications is “very low” because the potential risks of nitrosamine contamination is associated with long-term use of the affected drugs, and the recalled medicines have only been sold in Singapore since 2018.
Have Any Other Government Health Agencies Recalled Metformin?
Currently, only Singapore’s HSA has issued recalls for Metformin medications. However, as a result of the recalls, worldwide regulatory agencies such as the U.S. FDA, Health Canada, European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have opened investigations into possible NDMA contamination in their Metformin medications.
In statements from the FDA, EMA, Health Canada, and MHRA, the agencies claim that there is no evidence that any Metformin medications distributed in their respective territories are affected and have advised patients to continue taking their medications.
U.S. FDA’s Metformin Investigation
The FDA reacted to Singapore’s Metformin recalls by announcing an investigation into potential NDMA impurities in Metformin available in the United States. Currently, no Metformin recalls have been issued by the FDA and no NDMA contamination has been found in lots sold in the United States.
Pertaining to the affected samples outside of the United States, the FDA claims that “based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water.”
The investigation will determine whether there is NDMA in Metformin, and if so whether that amount is above the United States’ acceptable daily intake limit of 96 nanograms. The FDA “will recommend recalls as appropriate if high levels of NDMA are found,” according to a statement from Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Dr. Woodcock recommends that U.S. patients should continue taking Metformin while the investigation continues to keep their diabetes under control because “there are no alternative medications that treat this condition in the same way.”
European Medicine Agency’s Metformin Investigation
The EMA—the drug advising department for the European Union—has partnered with companies manufacturing and distributing Metformin within the EU to test the medication for NDMA. The results have thus far found no data indicating that EU Metformin medicines have been affected and recommends that patients in the EU should continue taking Metformin as prescribed.
The EMA is aware of trace amounts of NDMA found in a small number of Metformin medications outside of the EU; however, the organization claims that the levels of NDMA found in affected non-EU Metformin medicines are very low and appear to be within or even below the range people can be exposed to from other sources including water and certain foods.
Health Canada’s Metformin Investigation
Health Canada has asked drug manufacturers and distributors of Metformin to “test their own Metformin products” and will be “collecting samples from those companies to conducts its own testing.”
After the investigation, Health Canada announced that it is not aware of any Metformin products available in Canada that contain NDMA above the acceptable limits; however, it is working closely with international regulatory agencies to continually assess the concerns.
What is Metformin?
Metformin is a prescription medication available in both generic and brand name forms that helps those suffering from type 2 Diabetes by lowering blood sugar levels. The immediate-release form of the medication is Glucophage and the extended-release forms of the medication are Glucophage XR, Fortamet, and Glumetza.
How Does It Work?
In patients suffering from type 2 Diabetes, insulin (the hormone that helps the body remove extra sugar from the blood) naturally produced by the pancreas is unable to get sugar into the body’s cells where it can be properly converted into energy. Metformin, which belongs to a class of drugs known as biguanides, works by reducing the amount of glucose (sugar) made by the liver, decreasing the amount of glucose absorbed by the body, and increasing the impact of naturally produced insulin within the body.
What is NDMA Contamination?
N-nitrosodimethylamine (NDMA) is classified as a probable human carcinogen—meaning that the substance can cause cancer and belongs to class of impurities known as nitrosamines.
NDMA is commonly found in drinking water, some processed foods (pickled vegetables, salted fish, and processed meat products such as bacon and sausages), and as a result of air pollution.
NDMA was once used to make rocket fuel. However, after high levels of NDMA were uncovered in the air, soil, and water samples near manufacturing plants, NDMA use was discontinued. However, NDMA contamination occurs today through unintentional chemical reactions at industrial sites or in the manufacturing process of drugs.
Low levels of NDMA exposure are not dangerous. However, if more than 96 nanograms of NDMA are ingested daily, there is an increased risk of cancer.
Overexposure to NDMA can lead to:
- Abdominal cramps
Prolonged Exposure to NDMA Contamination can lead to tumors and cancer of the:
- Colon & Intestines
How GoldenbergLaw Can Help You
If you or a loved one contracted cancer after taking a drug recalled due to NDMA contamination, contact the dangerous drug attorneys at GoldenbergLaw. We are committed to promoting safety through accountability and providing you with the gold standard of advocacy.