According to the Food and Drug Administration (FDA), the tablets — Metformin HCl Extended Release Tablets, USP 750 mg — contain unacceptably high levels of NDMA that exceed the FDA’s limit of 96 ng/day.
The tablets’ lot number is MET200501 and they have an expiration date of July 2022.
The drugs were distributed to wholesalers nationwide.
The FDA has been investigatingTrusted Source the presence of NDMA in metformin drugs in the U.S. market since late 2010 after multiple batches of the diabetes drug sold outside the United States were found to contain low levels of the substance.
NDMA was also detected in multiple other prescription and over-the-counter (OTC) medications, including ranitidine and certain blood pressure drugs, earlier this year. The drugs have since been recalled.
The overall risk of developing cancer from medications contaminated with small amounts of NDMA is low. However, if you currently take metformin, it’s crucial to talk with your doctor about other treatment options.
“While hearing that our medicines — agents essential for our health and well-being — could be compromised in any way is certainly alarming, it is important to understand the magnitude of the risk, which is extremely low,” Dr. Amir Masoud, a Yale Medicine gastroenterologist and assistant professor of internal medicine, told Healthforcast.
What is NDMA and why is it harmful?
NDMA is classified as a probable human carcinogen, meaning it could potentially cause cancer.
We’ve all been exposed to low levels of the substance. NDMA has been detected in meat, vegetables, dairy products, soil, air, and water.
NDMA is all around us, Masoud explained.
The acceptable intake limit for NDMA in medications is 96 nanograms a day.
“The FDA does not expect to cause harm at levels below this cutoff. The risk of cancer is increased if people are exposed to it at higher levels at prolonged periods of time,” said Dr. Guy Mintz, the director of cardiovascular health & lipidology at Northwell Health’s Sandra Atlas Bass Heart Hospital in New York.
In high doses, NDMA may cause liver, lung, and kidney problems, according to studies conducted on animalsTrusted Source. The World Health OrganizationTrusted Source (WHO) says it can also lead to gastric or colorectal cancer.
“NDMA has been shown to increase the incidence of cancer in animals as well as cause liver fibrosis and tumors in rats,” says Mintz.
No human cancer cases have been directly linked to NDMA at this time.
It’s not entirely clear how NDMA gets into medications.
According to the U.S. Environmental Protection Agency (EPA), NDMA forms during natural and industrial processes involving chemical reactions.
NDMA may form during the drug’s manufacturing process or when they are packaged and stored, the FDA stated. Our bodies may also produce NDMA as a byproduct when digesting certain food and drugs.
“It appears that a perfect storm of sorts has to take place: The compounds that form NDMA may be present in the drug and, under certain conditions, may form after formulation of the drug,” says Masoud.