An investigation into the diabetes medication Metformin by the Food and Drug Administration (FDA) began in December 2019 after the drug was recalled in other countries. It was announced in May by the FDA that lab tests revealed levels of N-Nitrosodimethylamine (NDMA) that came in higher than recommended by the agency. Not long after the investigation began, five manufacturers issued voluntary recalls of their extended-release (ER) medications. NDMA might sound familiar, as it was the basis for the ranitidine (Zantac) recalls and high blood pressure medication recalls.
What has been recalled so far?
So far, high levels of NDMA have been found only in the Metformin ER medications. This drug is popular among people who suffer from Type 2 Diabetes and is used to improve the patient’s glycemic control.
- Granules Pharmaceuticals – 12 lots
- Lupin Pharmaceuticals – All lots (expansion of previous recall)
- Avkare (repackager for Amneal) – All lots
- PD-Rx Pharmaceuticals (repackager for Amneal) – 31 lots
- PD-Rx Pharmaceuticals (repackager for Marksans) – 26 lots
- The Harvard Drug Group (repackager for Apotex) – One lot (T-02134)
- Preferred Pharmaceuticals (repackager for Marksans) – Four lots (J0119M, K1419L, K2719J, A0220H)
- Apotex – All lots
- Amneal – All lots
- Marksans (labeled as Time-Cap) – One lot (XP9004)
- Lupin – One lot (G901203)
- Teva (labeled as Actavis) – 14 lots
Statement from the American Diabetes Association
The American Diabetes Association issued a statement related to the recall via Matt Petersen, Vice President, Medical Information and Professional Engagement for the association: “Patients should continue to take their metformin until their pharmacist supplies a different manufacturer’s product or their doctor prescribes a different treatment. Medications should not be stopped unless directed to do so by their doctor.”
What is NDMA?
N-Nitrosodimethylamine has been classified as a probable human carcinogen, which means high levels of it can lead to cancer. Despite this, it is found in dairy products, meat, water, and even vegetables. NDMA is not considered harmful when it is ingested in small doses. The risk of developing cancer increases when it is ingested at high levels for prolonged periods.
NDMA can contaminate a batch of medications in multiple ways: the conditions in which the medication is stored or packaged, the medication’s chemical structure, or the process in which the drug is manufactured.
Steps to take if you are prescribed Metformin
It is advised that you do not stop taking the medication in question if you take Metformin ER until you speak to your physician. This is the case even if a recall has been issued for the drug you are taking. It can be dangerous to stop taking prescribed medication without first speaking to a doctor. In fact, the FDA has recommended that doctors continue to prescribe Metformin when it is clinically appropriate. Testing conducted by the FDA did not find high levels of NDMA in immediate-release (IR) Metformin, which is the type of Metformin doctors prescribe the most.