FDA Asks Companies to Recall Diabetes Drug Metformin
- The FDA has asked companies to voluntarily recall a specific type of the diabetes drug metformin over a potential cancer risk
- The extended-release form of metformin – commonly prescribed to people with type 2 diabetes – was found to have a high level of N-Nitrosodimethylamine (NDMA)
- At a certain level, NDMA is considered to be a “probable carcinogen,” meaning it can cause cancer in humans
The FDA announced that a high level of a contaminant called N-Nitrosodimethylamine (NDMA), which is linked to cancer, was found in some versions of the drug. NDMA was found in several batches of the extended-release form of the drug, which is often prescribed to control high blood sugar in patients with type 2 diabetes. However, Dr. Marilyn Tan, chief of the Stanford Endocrine Clinic, tells SurvivorNet that most people with diabetes who take metformin take the immediate release form of the drug, and that version is still considered safe.
Read More“Patients should continue taking metformin tablets even after recalls occur, until they consult with their health care professional who can prescribe a replacement. Patients with type 2 diabetes could face dangerous health risks if they stop taking their prescribed metformin,” the agency said in a press release.
Dr. Tan says patients who are currently on the extended-release form of metformin may be able to switch to the immediate release form of the drug with few issues.
“In terms of medication efficacy, they're both equally effective,” Dr. Tan tells SurvivorNet. She also reiterated that until people on extended-release metformin can consult their physicians about changing their prescription, they should continue taking the drug.
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So, just how risky is extended-release metformin? It’s important to understand what NDMA is first before addressing that concern.
What is NDMA?
NDMA is a chemical that can be unintentionally formed during various manufacturing processes, according to the Centers for Disease Control and Prevention (CDC). People can be exposed to low levels of NDMA in a variety of ways — it can be found in foods like cured meats and fish, beer, tobacco smoke and even in some toiletry and cosmetic products. NDMA is labeled as a “probable carcinogen,” meaning it may cause cancer in humans.
Essentially, NDMA is all around us at low levels. When it comes to cancer risk, it’s difficult for medical professionals to say exactly how dangerous the substance is.
“We don't really know long term exactly what the risk is … we do know that there is some potential for cancer and liver issues,” Dr. Tan says.
The FDA considers the chemical generally safe as long as exposure does not exceed a certain limit and people are not exposed for a long period of time.
To avoid potential dangers, the FDA regularly tests and monitors products — like medications — to ensure that they only contain what the agency considers to be safe levels of contaminants like NDMA. Earlier this year, the agency recalled popular heartburn drug Zantac over high NDMA levels. This new metformin recall comes after the agency determined that the extended-release form of the drug had NDMA levels that were above the FDA’s “acceptable intake limit.”
The acceptable intake limit for NDMA is 96 nanograms per day for medications, according to the FDA.
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