EMA asks pharma to test diabetes drugs for NDMA

Dec. 4, 2019

Common diabetes drugs have become the newest target of an ongoing NDMA scare in pharma.

According to Bloomberg, the European Medicines Agency has asked drugmakers to begin screening widely used diabetes medications containing metformin for N-nitrosodimethylamine (NDMA), a probable human carcinogen. So far, the agency said that there have been no cases of the impurity found at dangerous levels in the EU’s supply of the drugs. But officials in Singapore recently recalled 46 medications including metformin after NDMA was detected above “acceptable levels.” 

Scrutiny of NDMA has been high in recent months following major global recalls of heart medications such as valsartan and ranitidine, a popular heartburn drug. The FDA’s most recent evaluation of the heart medication recalls is that the presence of NDMA was related to the use of solvents in the manufacturing process. With ranitidine, the toxin has been found to occur naturally in the medication.

The EMA has advised patients to continue taking medications containing metformin for now, and cautioned that the risks of not taking needed diabetes drugs outweigh the theoretical cancer risks related to NDMA.

Read the Bloomberg report.