Ensuring that your medications are safe is our top priority at Sona Pharmacy. The US Food and Drug Administration (FDA) recently recalled a common diabetes medication, and we want to ensure our patients understand this recall.
On May 28, 2020, the FDA announced that they have requested a voluntary recall of metformin extended-release (ER) formulations from five manufacturers. This medication is being recalled due to an impurity, NDMA, that has been identified as a possible carcinogen (a substance that could cause cancer).
Does NDMA sound familiar? It has been part of several recalls recently, including ranitidine and blood pressure medications. Small amounts of NDMA can be found in many foods and water sources, meaning that we may regularly consume NDMA in our diets, but these levels are so low that they are not thought to be harmful or lead to cancer.
What should patients know about the metformin ER recall?
There are several points we want all of our patients, and partner healthcare providers, to know:
- – For up-to-date information about affected products, please visit the FDA Recalls, Withdrawals, and Safety Alerts page.
- – There are additional manufacturers, besides the five manufacturers, that supply a significant portion of the U.S. market, and their products are NOT being recalled at this time.
- – FDA testing has NOT shown that metformin immediate-release (IR) formulations contain NDMA. Metformin IR is the most common type of metformin.
- – The FDA is asking that ALL manufacturers of metformin ER test each batch before it is released into the market.
– Most importantly, patients should continue to take metformin ER even after the recall, until their healthcare team finds a suitable replacement. This is because patients with diabetes could face health consequences if they stop taking metformin ER.
How do pharmacies handle medication recalls?
Ensuring that the medications are safe is a pharmacy’s most important job. When a medication is recalled by the FDA:
- -The FDA will release information about the recall including guidance for how patients, providers, and pharmacies should proceed.
- – Pharmaceutical manufacturers and distributors will inform pharmacies about specific products that are being recalled so these products can be removed from inventory.
- – Pharmacies can review records to help identify patients affected by the recall and contact these patients if needed.
- – Pharmacists can work with providers to help find suitable replacements for recalled medications if needed.
If you have questions or concerns regarding this recall, please feel free to call the Sona team at 828-298-3636.