Several manufacturers of metformin ER have been asked to voluntarily recall their metformin ER products by the FDA. Laboratory tests have revealed high levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA), which may increase the risk of cancer if consumed at high-doses for a long period of time. Amneal and Apotex were identified as having several contaminated lots in the FDA’s investigation, and both companies have recalled all lots of their metformin ER products out of an abundance of caution.
Metformin ER is a commonly used generic prescription drug for the treatment of type 2 diabetes and is often used as first-line therapy. Currently, the FDA has only asked five firms to voluntarily recall their products. There are several additional manufacturers of metformin ER that supply a significant portion of the U.S. market and they have not be affected by the recall.
At this point, it is unclear if the U.S. will face a drug shortage of metformin ER, but the reduction of manufacturers may cause a price jump for metformin ER. Additionally, some patients may be switched to higher priced brand name medications and we may see an increase in spend for diabetes management overall.
It is critical to keep an eye on the changing dynamics for this already high-cost therapeutic category and Truveris can provide strategic support to navigate these diabetes market changes.