Product News and Recalls

Metformin Recalls Continue Over Contamination Risk

metformin recalled after NDMA contamination discoveredTwo lots of diabetes drug metformin produced by Kansas City, Missouri drug maker Nostrum Laboratories are being pulled from pharmacy shelves over concerns that they might be contaminated with a cancer-causing compound. The compound, known as NDMA or nitrosamine, was detected in the company’s 750mg HCI extended-release tablets at levels that exceed federal regulations.

NDMA is a naturally occurring chemical that is found in everything from the fruits you eat to rocket fuel. It is of little concern at low levels, however, higher levels can lead to the onset of various types of cancer. It has been detected in a variety of pharmaceuticals in recent months and the impact has been recalls of blood pressure medications, antacids, and now diabetes drugs.

Interestingly, at least one recent instance of NDMA contamination wasn’t caused by any sort of external factor. After an exhaustive search and countless hours of research, scientists discovered that ranitidine – the active ingredient in Zantac – produces NDMA on its own. The speed of production increases with temperature, and researchers believe that most production happens during transit from overseas labs to US shores in non-temperature-controlled shipping containers. However, NDMA production was still found to take place at ambient room temperature; such as within a home medicine cabinet, albeit at a much slower pace.

Whether the ongoing metformin recalls are the byproduct of a chemical reaction such as with Zantac, or the introduction of the chemical during the manufacturing process remains to be seen. But the list of drugs showing at least some degree of NDMA contamination was significant to begin with. The addition of metformin only adds fuel to the fire.