The Food and Drug Administration (FDA) voluntarily recalled Metformin in January 2022. The recall was prompted by concerns about elevated levels of the cancer-causing contaminant N-nitrosodimethylamine (NDMA) in some preparations of extended-release Metformin. It is considered one of the most effective oral diabetes medications. In this article, we are going to explore what you can do if this recall affects you, what you need to know about NDMA, how it ends up in the drug, and steps to take if there’s another recall. Additionally, you can buy Metformin from Canada to treat your diabetes.
What Is NDMA?
As a contaminant, N-Nitrosodimethylamine (NDMA) can be found in air pollution, water, and foods like dairy products, vegetables, and cured and charred meats. It is common for everyone to be exposed to NDMA to some extent, but low levels typically do not cause any adverse health effects. There is a current FDA limit of 96 nanograms per day for NDMA in prescription drugs.
How Does NDMA End Up in Metformin?
NDMA has previously been used to produce antioxidants, rocket fuel, and softeners for nitrile rubber. As of 2023, NDMA is only used for research purposes. However, the chemical can be produced as an accidental byproduct of chlorinating wastewater. Byproducts of chemical reactions may unintentionally produce and release NDMA. For example, alkylamines can produce NDMA when they react with nitrogen oxides, nitrous acid, or nitrite salts.
Clinical endocrinologist Karl Nadolsky, DO, said Metformin can be contaminated with NDMA during manufacturing. Metformin may also produce NDMA through its structure. In most cases, the chemical is a contaminant in the medication.
Which Types of Metformin Are Recalled?
A limited number of extended-release (ER) Metformins are included in the FDA recall. No exemption exists for immediate-release (IR) Metformin, the most commonly prescribed type. According to the FDA, all IR Metformin tested had levels of NDMA that were low to non-detectable. In August 2022, all seven pharmaceutical companies recalled their ER Metformin tablets from retail stores:
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Apotex Corp.
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Amneal
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Granules Pharmaceuticals, Inc.
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Lupin Limited
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Teva Pharmaceuticals USA, Inc.
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Bayshore Pharmaceuticals, LLC
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Marksans Pharma Ltd.
Is It Safe to Take Recalled Metformin?
As a precaution, the FDA informed patients taking Metformin to resume taking it until their prescriptions were replaced before January 2022. Different treatment options may be available from a healthcare provider. People with type 2 diabetes can have dangerous side effects if they stop taking Metformin. In this case, the benefits are weighed against the risks. It can be life-threatening if the patient’s blood sugar gets too high. Symptoms of high blood sugar (hyperglycemia) include:
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Blurry vision
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Extreme thirst
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Dry mouth and skin
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Tiredness
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Frequent urination
You may wonder why you should take a medication contaminated with a potentially cancer-causing ingredient. There may be no need to worry about recalls. To find out what alternatives are available, speak to a healthcare provider or pharmacist as soon as possible. You must be exposed to a certain amount of NDMA over your lifetime. In contrast, high blood sugar can be extremely dangerous in the short term.
Why Shouldn’t You Stop Taking Metformin?
As Metformin lowers your liver’s release of sugar into your blood, your body becomes more sensitive to insulin’s effects. Sudden discontinuation of use can lead to dangerously high blood sugar levels. As a result, you may experience:
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Headache
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Having difficulty concentrating
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A feeling of increased thirst or hunger
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Dry mouth
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Fatigue and drowsiness
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Vision is blurred
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Bloating
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Dehydration
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A feeling of shortness of breath
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A coma or death
A chronic high blood sugar level can damage small blood vessels (like the ones in the eyes, the same ones that supply your kidneys with blood) and large blood vessels. The extended-release Metformin is usually more tolerable than immediate-release Metformin. You may experience gas, bloating, and diarrhea if your Metformin was recalled and your doctor switched you to an immediate-release version.
Most of these are transient side effects that can be annoying but can be resolved within a few days. Consult your doctor about mitigating this and checking your blood sugar levels. A doctor or pharmacist can work with you to find another treatment option if you’re taking a recalled type of Metformin, but in the meantime, keep taking the medication as prescribed. It is riskier to stop taking the medication altogether than to be exposed to NDMA for a short period.
How Does NDMA Exposure Affect Your Health?
Every day, you’re likely exposed to NDMA through the air or water you breathe. NDMA and other nitrosamines are sometimes added to foods as preservatives. Low levels of exposure may not be noticeable, but too much exposure can cause symptoms such as:
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Having a headache
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Fever
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Symptoms of nausea
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Jaundice
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Vomiting
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Having abdominal cramps
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Unsteadiness
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Liver enlargement
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The liver, kidneys, and lungs are less functional
As a result of studies published in the BMJ journal connecting long-term exposure to NDMA with certain types of cancer, the contaminant is also considered a “probable human carcinogen” by the Department of Health and Human Services. According to the FDA, NDMA exposure at low levels won’t cause any long-term health problems. Until you can talk to your doctor about your next steps, you should keep taking your medication. Additionally, you can buy Metformin online at the best Canadian online pharmacy, which is the most affordable and genuine medication site.
Final Thoughts
If you’re taking Metformin and are affected by the recall due to NDMA contamination, it’s crucial to continue taking your medication until you can consult your healthcare provider. While NDMA exposure poses potential health risks, stopping your medication abruptly can lead to dangerously high blood sugar levels, which can be life-threatening. The FDA advises against discontinuing Metformin without an alternative treatment plan. Remember to keep in touch with your doctor or pharmacist for guidance and to monitor any changes in your health. Your safety and well-being are the top priorities, and healthcare professionals are there to support you through this process.
