The Food and Drug Administration(FDA) has announced that the common diabetes drug metformin may contain high levels of a cancer-causing drug. If you take metformin, it is essential to consult with your doctor about other treatment options.
FDA Recalls Metformin Diabetes Drugs
FDA discovered high levels of N-Nitrosodimethylamine in some extended-release tablets. It is a chemical that could cause cancer.
A new batch of metformin extended-release medicines that have been commonly used to treat type 2 diabetes have been recalled because of elevated levels of a carcinogen known as N-Nitrosodimethylamine (NDMA).
According to the FDA, Metformin HCl Extended-Release Tablets, USP 750 mg contain unbelievable amounts of NDMA that exceed the FDA’s limit of 96 ng per day.
The pills’ lot number is MET200501 and the expiration date is July of 2022. These tablets were distributed to wholesalers nationwide.
The recall is linked to a previous recall issued in November 2020. Many other generic drug makers were requested to recall metformin diabetes drugs because of similar NDMA concerns last May.
Since late 2010, the FDA has been examining the presence of NDMA in metformin tablets in the United States market. After many batches of diabetes medicines sold outside the US were discovered that they contain low levels of the substance.
Earlier this year, NDMA was also found in the many other drugs and over-the-counter(OTC)medications that include ranitidine and in some blood pressure tablets. These drugs have been examined.
The overall risk of developing cancer from drugs containing small amounts of NDMA is low.
What Is NDMA and Is It Harmful?
NDMA, also called N-nitrosodimethylamine is a cancer-causing substance that has been recently found in some drugs. Water and many food items may contain low amounts of NDMA and they don’t cause any harm.
NDMA is considered a probable human carcinogen that could cause cancer. People have been exposed to low levels of the substance. NDMA can be found in vegetables, meat, dairy products, soil, water and air.
The acceptable intake limit for NDMA in tablets is 96 nanograms per day.
Dr Guy Mintz, the director of cardiovascular health & lipidology at Northwell Health’s Sandra Atlas Bass Heart Hospital in New York stated that the FDA didn’t expect to cause harm at high levels. The risk of cancer will increase if people take high levels of NDMA for prolonged periods.
If people take high doses, it can cause kidney, liver and lung problems, according to research conducted on animals.
According to the World Health Organization(WHO), it can lead to colorectal or gastric cancer.
Dr Guy Mintz says NDMA is shown to improve the risk of cancer in animals and also cause liver fibrosis and tumours in rats. No human cancer cases found associated with NDMA at this time. However, it is required to find how NDMA gets into drugs.
As stated by the U.S. Environmental Protection Agency (EPA), NDMA develops during natural and industrial processes involving chemical reactions.
NDMA may be produced when they are packed or stored or during the drug’s manufacturing process. Our bodies can produce NDMA as a byproduct when we take certain food or drugs.
What to Do If You Take Metformin
According to the FDA, patients who take extended-release metformin drugs shouldn’t stop the medication suddenly.
Dr Mintz says if you do so it could negatively affect blood sugar levels and may lead to hospitalizations for ketoacidosis and hyperglycemia.
You should continue to take medication until your doctor tells you about other options.
According to Dr Minz, several alternative options such as short-acting versions of metformin and other diabetes medications — SGLT2 inhibitors and GLP1 medications.
It is important to understand that stopping or changing medication abruptly without consulting your physician can lead to direct health risks.
The new batch of metformin extended-release medicines used to treat type 2 diabetes has been willingly examined due to the high dose of a carcinogen known as N-Nitrosodimethylamine (NDMA). As per health experts, you shouldn’t stop your medications that could lead to negative health consequences. It is better if you consult with your doctor about alternative treatments options.