Type 2 diabetes medicine metformin recalled due to high levels of carcinogen

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Farah Javed

Two metformin hydrochloride medicines mostly used to treat Type 2 diabetes patients have recently been recalled. Through investigation by the FDA, these medicines have been found to contain high levels of NDMA, a cancer-causing containment.

Marksans Pharma Limited, the Indian pharmaceutical company that produces the recalled Metformin Hydrochloride Extended-Release Tablets USP 500mg and Metformin Hydrochloride Extended-Release Tablets USP 750mg, initially recalled them in June.

During routine testing for NDMA in medicine, the company found an amount above the allotted quantity in drugs. These pills are sold under the label Time-Caps Lab, Inc., located in Farmingdale, New York.

The recalled pills were meant to serve the same purpose as other drugs containing the organic compound. Metformin hydroxide maintains the body’s insulin and controls blood sugar levels. For those diagnosed with Type 2 diabetes, their bodies cannot produce a sufficient amount of insulin, which breaks down glucose from food to be converted into energy in cells. Their blood glucose levels are then too high and without the much-needed insulin, which, in turn, puts them at a higher risk for long-term health problems like dementia or heart disease.

On top of these potential health problems, patients prescribed these two metformin hydrochloride medicines must now worry about cancer. The recalled tablets had higher amounts than the FDA approved 96 nanograms per day of N-Nitrosodimethylamine or NDMA, a carcinogen.

Considering these pills are on the World Health Organization’s List of Essential Medicines and metformin “has become the most prescribed glucose-lowering therapy worldwide,” it is safe to say that many people have taken these pills across the globe for many years.

The recall begs the question, especially to long time users of these two medicines, of just how long the carcinogen has been in metformin hydrochloride products. The answer, however, is unknown.

“The FDA does not have scientific evidence to determine how long NDMA has been present in metformin products and we are investigating the root cause of its presence,” according to the FDA’s official website.

Though the recalled drugs’ effects are still being investigated, the FDA provided a description of these pills in the official recall report. The tainted metformin hydrochloride pills are “off white, capsule-shaped, biconvex tablets, capsule-shaped101” on one side and plain on the other side and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule-shaped, biconvex tablets, capsule-shaped” on one side and plain on the other side.”

In regards to whether patients should keep taking the medicine or not, “The FDA advises users to continue taking the recalled tablets until a medical professional provides a replacement or alternative treatment option,” according to New York Post. Diabetic patients now know that the capsules they have taken could put them at high risk of cancer. However, they have no choice but to take their metformin hydroxide because their insulin levels would go unchecked without it. This could then lead to more immediate health problems.

Marksans Pharma Limited is not the only pharmaceutical company to have recalled metformin hydroxide pills, to make matters worse. In the past year alone, seven companies were forced to recall their products due to the same reason; their medicine contained high amounts of the carcinogen, according to CNN.

With the increasing number of recalled products, the FDA has released an official list of recalled metformin hydroxide products. The 18-page list reveals that though some only have specific batches recalled, others are denoted with “all”, meaning all batches of a type of metformin product are defected.

Some of the companies on the list include Amneal Pharmaceuticals in Bridgewater, Bayshore Pharmaceuticals, LLC, Teva Pharmaceuticals and Parsippany.

Marksans Pharma Limited sent out letters and press releases to inform its customers that it will replace all recalled products. However, the issue that is not being addressed is what will be done to help the diabetic patients who are suffering at the hands of a problem they played no role in causing.

Though the FDA has issued statements and is investigating, it must educate the public on the list of companies that contributed to the massive recall so that patients can know if their medicine has NDMA in it or not.

While manufacturers simply produce new batches, Type 2 diabetes patients are left to continue taking a drug that exposes them to a carcinogen or go without the medicine and face terrible health conditions. In the end, the pharmaceutical industry leaves patients in a situation with no silver lining.