(CMR) The US Food and Drug Administration (FDA) has recommended a voluntary recall of certain extended-release (ER) versions of metformin after testing revealed a contaminant in these products. The HSA, in keeping with this advisory, is recalling all Metformin ER tablets.
The extended-release metformin, a popular drug used to control high blood sugar in people with Type 2 diabetes is being recalled because it may include a carcinogen. On May 28, the FDA said laboratory testing “revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit” in the extended-release form of the drug.
“The FDA is continuing to work closely with manufacturers to ensure appropriate testing. Assessments are underway to determine whether metformin ER recalls will result in shortages and the agency will work closely with manufacturers to prevent or reduce any impact of shortages.”
NDMA is a probable human carcinogen, meaning it could cause cancer.
Metformin is the most commonly prescribed drug used to treat type 2 diabetes worldwide. As a result of the advisory, HSA’s manufacturer, Apotex Corp has recalled metformin hydrochloride 500 mg Extended Release tablets. The recall does not include the regular release Metformin 500mg tablets.
For those patients taking Metformin ER, please contact your physician or pharmacist to facilitate the relevant adjustment.