Controversial Diabetes Drug Recalled

Sofia Vinueza , Business Manager

On Oct. 5, 2020, Marksans Pharma and Sun Pharmaceutical Industries recalled Metformin, a diabetes drug, because of traces of carcinogen NDMA, nitrosodimethylamine, found in the drug. Much controversy has surrounded this drug since Dec. 2019.

The first statement released in Dec. 2019, written by director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., spoke on the impurities found in the diabetes drug outside of the U.S. In Feb. 2020 the results for the tests done were released and found high levels of NDMA in the medication. In May 2020, a press release announced the recall of Metformin. Following this announcement, many pharmaceutical companies took action and recalled their lots.  

 Marksans Pharma and Sun Pharmaceutical Industries released a detailed statement on the specific recalled products in Oct. 2020.

Other companies that have also recalled this drug include: Bayshore Pharmaceuticals, Avkare, PD-Rx Pharmaceuticals, PD-Rx Pharmaceuticals, The Harvard Drug Group and Preferred Pharmaceuticals. 

NDMA found in Metformin may increase chances of developing cancer. Metformin contains a concentration of NDMA higher than 96 nanograms consumed each day. 

Metformin tablets are prescribed to type two diabetes patients. The drug is designed to lower glucose levels. In other words, to help those with high blood sugar. 

Zantac, used for acid reflux, was also found to have NDMA and companies recalled it in Apr. 2020. Back in Sep. 2019, the Food and Drug Administration released a warning for this medication when stored at higher temperature. 

The FDA is still investigating what other drugs contain NDMA and trying to find out where it originates from. Some medications do contain NDMA, but a safe amount, up to 0.096 micrograms or 0.32 parts per million of NDMA per day, an amount approved by the FDA.