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The Food and Drug Administration (FDA) had recalled some of the metformin. But why metformin recall? Let’s first learn what FDA is for. FDA is the entity responsible to protect and promote public health by making sure the safety, efficacy, and security of drugs, biological products, and medical devices. It is also the one that regulates the safety of the food supply, cosmetics, and products that emit radiation. In case a drug creates a problem for public health, the FDA makes sure to analyze its risks and take them off the market.
In case the FDA detects that a medication has been contaminated with a substance harmful to the population, they immediately ask the company to recall (or take back) their product from the market. This way they ensure that the medications being consumed are safe for the population and won’t cause any harm.
What is Metformin?
Diabetes is one of the most common metabolic diseases found nowadays. Research has found that over 34.2 million Americans, meaning 1 in 10 have diabetes and over 88 million (meaning 1 in 3) have prediabetes. Diabetes causes high blood sugar due to a resistance or a decrease of the hormone insulin which helps move the sugar found in your blood into your cells so that it can be used as energy. Untreated high blood sugar can cause serious damage to your nerves, eyes, kidneys, and other organs.
Metformin is one of the most common drugs used to treat Type 2 Diabetes or other ailments related to insulin resistance. Combined with a healthy diet and exercise this medication helps regulate blood glucose levels. Metformin works by increasing the sensitivity to insulin and reducing the amount of glucose produced by the liver. One of the greatest advantages of metformin is that it does not cause weight gain unlike other medications to treat diabetes.
Why is Metformin Recalled?
The FDA announced that some batches of metformin we tainted with a compound called N-nitrosodimethylamine (NDMA). This component with long-term exposure has been found to cause cancer in animals and could potentially cause cancer in humans. NDMA is commonly found in smoked and cured meats such as sausages, dairy products, fried foods, and even water. Low levels of NDMA are of no concern since they will not cause any harm, however, larger, and longer exposure to the substance could potentially lead to cancer.
The metformin recall stated by the FDA applies only to extended-release metformin tablets with doses of 500-750 mg were the ones recalled by FDA. Immediate release tablets were not found to have any contamination with NDMA. Both medications, extended and immediate release, are equally effective treatments. Nonetheless, taking immediate-release could mean you take more drugs throughout the day. If you are thinking of making the switch, remember to always as your healthcare provider for guidance.
Although there has not been an official relationship as to where the metformin was contaminated, theories state that they could have been contaminated during the manufacturing process by using water contaminated with NDMA, or even in the conditions that were stored or packaged. More research needs to be done to determine where the drugs were contaminated.
Companies of whose Metformin Recalled
Over thirteen companies have recalled their extended-release metformin due to the possibility of being contaminated with NDMA. Some companies even recalled voluntarily their medications due to possible contamination. The companies listed by the FDA are:
• Amneal Pharmaceuticals.
• Apotex Corp.
• Avkare Inc.
• Denton Pharma (Marksans).
• Direct Rx.
• Lupin Pharmaceuticals.
• Nostrum Laboratories.
• PD-Rx Pharmaceuticals.
• Preferred Pharmaceuticals .
• RemedyRepack Inc.
• Sun Pharmaceuticals
• Teva Pharmaceuticals.
In case you want further information regarding the metformin recalled by the FDA you can also visit their website. (https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-metformin-products)
Should I stop taking Metformin?
If you find that the metformin you are taking comes from one of the companies named by the FDA, this does not mean you should stop taking your medication. The FDA recommends you continue your medication and consult with your healthcare professional so that they can help you find a different treatment option available. By any means do not stop taking your medication or switch to another brand without further instructions from your healthcare provider.
Conclusion on Metformin Recall
The FDA regulates the medication we take to make sure it will not cause us any harm. In case you are taking extended-release metformin, make sure it does not come from one of the companies listed above or make sure to check the FDA’s website. If you are taking metformin from one of the companies listed, do not stop taking your medication. Make an appointment with your healthcare provider to check the different available options available for you to switch to another brand. Remember that metformin is just an aid to manage your blood glucose levels, exercise and a healthy lifestyle will complement your medication to make sure your blood glucose levels stay in a healthy range.
AHMET ERGIN, MD, FACE, CDCES, ECNU
2260 Palm Beach Lakes Blvd. Ste 212 Unit #7
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