Problem

Contamination of pharmaceuticals

Other Names:
Impure medicinal drugs
Incidence:

As reported in 2020, a US pharmacy, Valisure, has tested and detected high levels of N-Nitrosodimethylamine (“NDMA”) in specific batches of prescription drug products containing metformin, a drug used to control high blood sugar in patients with type 2 diabetes. (The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) have classified NDMA as a Group 2A compound, thereby defining it as “probably carcinogenic to humans. The carcinogenic nature of nitrosamines in general, and NDMA specifically, has been well documented in the scientific community since the 1960s.) This is not the first report of nitrosamine contamination. It was only after Valisure identified NDMA in ranitidine and Zantac products that the FDA acted to removed drugs contaminated with NDMA off the market.

 

Furthermore, the presence of this probable carcinogen in a medication that is taken daily by adults and adolescents for a chronic condition like diabetes, makes this finding particularly troubling.”

Problem Type:
G: Very specific problems
Date of last update
25.03.2020 – 06:44 CET