The FDA has recommended a voluntary recall of extended-release (ER) formulation of metformin due to excessive levels of N-nitrosodimethylamine (NDMA).
What is Metformin?
Metformin is an oral diabetes medicine that helps control blood sugar levels. Metformin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Metformin is sometimes used together with insulin or other medications, but it is not for treating type 1 diabetes.
Why was Metformin recalled?
The recall was instigated after the FDA became aware of reports of higher levels of NDMA in certain ER formulations of metformin through a citizen petition filed by a private laboratory. The agency confirmed unacceptable NDMA levels in some, but not all, of those lots.
Five pharmaceutical firms, in particular, are being contacted by the FDA with notices recommending they voluntarily recall their products.
What is the carcinogenic contaminant?
The contaminant, NDMA is classified as a probable human carcinogen, meaning it could potentially cause cancer.
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 FDA and the international scientific community do not expect it to cause harm when ingested at low levels.
The FDA’s acceptable intake limit for NDMA in drug formulations is 96 nanograms per day. The FDA does not expect nitrosamines to cause harm when ingested at or below the acceptable intake limit levels (such low levels of nitrosamines are present in foods at low levels and ingested as part of usual diets) even over a long period of time (such as a 70-year lifespan).
Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above-acceptable levels over long periods of time, however, the FDA does not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.
What to do if you take this drug?
The FDA recommended that 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 FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate. FDA testing has not shown NDMA in immediate-release (IR) formulation of metformin.
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