The agency said the drugs likely contained N-nitrosodimethylamine, a likely carcinogen, beyond acceptable limits.
The U.S. Food and Drug Administration (FDA) said Thursday it had recommended five drug companies to voluntarily recall their diabetes drug metformin after the agency discovered high levels of a possible carcinogenic impurity in some versions of the drug.
The agency said the drugs contained the probable carcinogen N-nitrosodimethylamine (NDMA) beyond the acceptable limits in their sustained-release formulations only.
NDMA contamination was responsible for the recall of the Zantac heartburn drug sold by Sanofi SA and certain generic versions of the treatment last year.
The FDA, which has announced that it will post the company’s recall notices on its website, has named Canadian company Apotex Corp as one of the companies whose metformin tablets have high levels of NDMA. The names of the other four companies have yet to be released.
However, the agency said that patients should continue to take metformin tablets even after the reminders, until they consult their health care professional who can prescribe a substitute.
In December, the FDA started an investigation into metformin, which is used as an initial treatment for patients with type 2 diabetes.
Online pharmacy Valisure said in March that its independent tests showed elevated levels of NDMA in metformin manufactured by 11 companies, including Amneal Pharmaceuticals Inc and Aurobindo Pharma Ltd.
(With the exception of the title, this story was not edited by GalacticGaming staff and is published from a syndicated feed.)
