(Image source from: diatribe.org)
High levels of a possible cancer-causing impurity was found by The US Food and Drug Administration in some versions of the diabetes drug metformin. Five Pharmaceutical companies were asked to recall the drug.
In extended-release formulations, the agency found out that the drugs contained the probable carcinogen N-nitrosodimethylamine (NDMA) and this exceeded more the acceptable limits.
Last year, the drug Zantac for heartburn sold by Sanofi SA was asked to be recalled due to NDMA contamination.
As of now, FDA has only revealed the name of one among the 5 companies named Apotex Corp whose metformin tablets have high levels of NDMA. Further, the company recall notices would be posted on its websites. Having said, names of the four other firms have not been revealed yet.
Until the health care professional can prescribe a replacement, the agency has asked patients to continue taking metformin tablets even after recalls.
Metformin was investigated by FDA in December. Patients having Type 2 diabetes in their initial stages are given this medicine.
According to another online pharmacy Valisure, in the month of March when metformin was tested, they found high levels of NDMA in 11 companies
Online pharmacy Valisure said in March that its independent tests showed high levels of NDMA in metformin made by 11 companies. Among these 11 companies, names of two companies were Amneal Pharmaceuticals Inc and Aurobindo Pharma Ltd.
By Neha Makhija