November 05, 2020

Type 2 Diabetes Drug Recalled Due to Possible Carcinogen

On November 2, Nostrum Laboratories announced that it was voluntarily recalling two lots of a widely used type 2 diabetes medication Metformin. The recall comes as a result of testing that revealed levels of nitrosamine, or NMDA, above acceptable limits. Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels or for long periods of duration. Ingestion up to the acceptable daily intake limit is not expected to create an increased risk of cancer.Nostrum has not received any adverse event reports related to the recall, but it has been notifying distributors as well as arranging for return of the recalled product.

This is the latest of a series of metformin-related recalls which have been potentially linked to cancer-causing contaminants in the drug. The recalls have applied to metformin tablets between 500mg and 750mg. The FDA is investigating NMDA’s origin. FDAalso announced on September 1 the availability of guidance for industry recommending steps that manufacturers should take to detect and prevent objectionable levels of nitrosamine impurities on active pharmaceutical ingredients and drug products.