Carcinogen in Metformin Leads to Recall | Alonso Krangle, LLP

Carcinogen in Metformin Leads to Recall

 In Blog, Dangerous Drugs

Metformin Is Latest Drug To Face Recall Because Excessive Levels Of Dangerous Carcinogen

The recent recall of metformin makes it the third popular drug to be pulled from shelves in recent months because it contains a dangerous carcinogen. Some companies have begun voluntary recalls of particular lots of metformin. Metformin has already been the subject of widespread recalls in Singapore and Canada.

Bloomberg reported that the FDA conducted testing on metformin and discovered unacceptable levels of N-Nitrosodimethylamine (NDMA). Sarah Peddicord, a spokeswoman from the FDA, told Bloomberg that the higher levels of NDMA were limited to some extended-release (XR) tablets.

Independent Testing Found Excessive NDMA in XR Metformin

Valisure, an online pharmacy that conducts independent testing of the drugs it sells, received metformin samples from people across the country. Its tests in March revealed contamination in the extended-release version of the pills. Valisure found “NDMA exceeding acceptable limits in versions made by Amneal Pharmaceuticals LLC, Aurobindo Pharma Ltd., and Lupin Ltd., among other companies.”

NDMA Can Cause Cancer

NDMA is, according to the World Health Organization, a “probable human carcinogen.” NDMA might cause cancer to people. NDMA used to be a component of rocket fuel and is now found in small amounts in groundwater, soil, and water.

Doctors prescribe metformin to treat type 2 diabetes. According to Bloomberg, nearly 21 million prescriptions for the extended-release version of metformin were written in 2019. The extended-release version of metformin makes up ¼ of all metformin prescriptions. No one has found excessive NDMA levels in ordinary immediate-release tablets.

Other Drugs Containing NDMA Have Been Recalled

Metformin is one of several drugs found to contain unacceptable levels of NDMA.

Zantac and Valsartan were pulled from the market after the carcinogen was found in multiple lots of the drugs.

People around the country are filing lawsuits against the manufacturers of those drugs for failing to warn them about the risk of developing cancer.

“The presence of this carcinogen in metformin where multiple tablets can be taken daily and often for a lifetime diabetic condition, makes this finding particularly concerning,” stated Deanna Akinbajo, the chief pharmacist at Valisure.