High levels of carcinogen found in Metformin

A known carcinogen, N-nitrosodimethylamine (NDMA), that is present in Metformin, has been found to be above acceptable levels, so the FDA has launched an investigation into NDMA levels in the Metformin that is sold in the USA.

Global health regulators have been and are currently looking into whether widely used diabetes drugs may contain unsafe levels of the carcinogen NDMA, which has previously been found in heart and gastric medications.

The FDA said in a statement that the agency is testing samples of Metformin sold in the U.S. for NDMA, and that it will recommend recalls of the medication as appropriate.

NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables.

Everyone is exposed to some level of NDMA, the Acceptable Daily Intake (ADI) limit for NDMA in the U.S. is 96 nanograms. NDMA may increase the risk of cancer if people are exposed to it above these levels and over long periods of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit, every day for 70 years, is not expected to have an increased risk of cancer.

Jeremy Kahn, an FDA spokesman wrote in an e-mail, ‘The agency is in the beginning stages of testing Metformin; however, the agency has not confirmed if NDMA in metformin is above the ADI limit of 96 nanograms in the U.S.”

Kahn went on to say diabetes is a serious condition and patients who take metformin shouldn’t stop taking their medication without first talking to their doctors.

The (EMA) European Medicines Agency has also said companies should test for high levels of NDMA in metformin. No dangerous levels have been detected in EU supplies to date, and patients should continue taking their diabetes treatments as prescribed. Metformin is made globally by numerous generic drug-makers. NDMA is known to cause cancer in animals and is classified as a possible human carcinogen.

Poland’s health minister, Lukasz Szumowski, said earlier that officials were scrutinizing metformin-containing drugs, but that no products would be pulled from the market as NDMA had been found in only trace amounts. He also urged patients to continue taking their medications, as the benefit of diabetes treatment outweighed any theoretical cancer risk.

In Singapore health officials have recalled 3 of 46 versions of Metformin marketed there after finding NDMA amounts “above the acceptable level.”

Singapore’s Health Sciences Authority said that the recalled drugs had only been sold locally for a short period of time and the risk to patients who had taken them is low.

The FDA went on to explain that ‘These investigations take time. We understand that these issues affect patients’ health and well-being in many ways…the FDA will communicate any information we have scientifically confirmed to ensure the public knows as much as possible as soon as possible.”

Metformin is a medication primarily used to treat type 2 diabetes. It works through several mechanisms:

• Reducing Glucose Production in the Liver: Metformin decreases the amount of glucose produced by the liver. This is primarily achieved by inhibiting the enzyme hepatic gluconeogenesis, which plays a critical role in glucose production.

• Increasing Insulin Sensitivity: Metformin enhances the sensitivity of muscle cells to insulin, allowing these cells to take in glucose more effectively. This reduces the amount of glucose in the bloodstream.

• Decreasing Intestinal Absorption of Glucose: Metformin slows the absorption of glucose from the intestines, contributing to lower blood glucose levels after meals.

• Improving Lipid Profiles: Metformin has been shown to improve lipid profiles by reducing levels of triglycerides and low-density lipoprotein (LDL) cholesterol while increasing high-density lipoprotein (HDL) cholesterol.

These combined effects help lower blood glucose levels and improve overall blood sugar control in people with type 2 diabetes. Metformin is often prescribed as a first-line treatment due to its efficacy and relatively favorable side effect profile.