(RxWiki News) The US Food and Drug Administration (FDA) is alerting the public about an additional voluntary recall of certain extended-release metformin products.
The FDA is notifying patients about potentially higher-than-acceptable amounts of a possible cancer-causing impurity in specific metformin-containing products.
Metformin is a common medication used to treat high blood sugar in patients with type 2 diabetes.
This notification is due to an impurity called N-Nitrosodimethylamine (NDMA). Based on results from laboratory tests, NDMA has been classified as a substance that could cause cancer.
In May of this year, the FDA issued a warning regarding this impurity. This warning involved five drug companies that issued a voluntary recall for specific lots of extended-release metformin tablets. These companies included Apotex, Amneal, Marksans (labeled as Time-Cap), Lupin and Teva.
Now, additional companies and repackagers are issuing recalls due to the possibility that their products may contain amounts of NDMA above the acceptable intake limit:
- Granules Pharmaceuticals, Inc. – 12 lots
- 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
- Preferred Pharmaceuticals (repackager for Marksans) – Four lots
For consumers, the FDA recommended the following steps:
- Continue taking your medication until you have a replacement. Metformin treats high blood sugar, and stopping the medication could be dangerous.
- If your medication was recalled, follow the exact recall instructions for the specific company. This information can be found on the FDA’s website.
The FDA said it will continue to investigate this problem and provide more information as it becomes available.
The agency strongly encouraged consumers to report any issues with any of these products to its MedWatch Adverse Event Reporting program.
Speak with your pharmacist if you have any questions.