Impurities Found in Diabetes Rx Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) is alerting the public about the voluntary recall of certain extended-release metformin products.

The FDA is notifying patients about higher-than-acceptable amounts of a possible cancer-causing impurity in several lots of metformin-containing products.

This notification is due to an impurity called nitrosamine impurity N-Nitrosodimethylamine (NDMA). Based on results from laboratory tests, NDMA has been classified as a substance that could cause cancer.

Metformin is a common medication used to treat high blood sugar in patients with type 2 diabetes.

This warning involved five drug companies. After the FDA contacted them, these companies issued voluntary recalls of certain lots of metformin. The following companies issued a voluntary recall:

  • Apotex – All lots (500 mg)
  • Amneal – All lots (500 mg and 750 mg)
  • Marksans (labeled as Time-Cap) – One lot (XP9004) (500 mg)
  • Lupin – One lot (G901203) (500 mg)
  • Teva (labeled as Actavis) – 14 lots (500 mg and 750 mg)

The FDA noted that testing had not shown NDMA in immediate-release metformin products. The agency asked all companies that make extended-release metformin to look at NDMA levels in these and other at-risk products.

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.

Speak with your pharmacist if you have any questions.



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