TWO lots of diabetes controlling drug of Bangladesh origin were recalled in the US last month for containing a compound that has the potential to cause cancer. The drugs were manufactured by Beximco Pharmaceuticals in Bangladesh, to be marketed in the USA by Bayshore Pharmaceuticals. The US Federal Drug Administration announced that Bayshore is recalling two lots of the drug called Metformin Hydrochloride Extended-Release because the drugs contained a carcinogenic compound called NDMA.
Media reported that the US-FDA tested the medicine and found an excess of the acceptable daily intake limit of the compound. Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from eight lots of the tablets manufactured using the same ingredient of the failed lot. Out of eight lots, one lot of 750 mg tablet and one lot of 500 mg have shown NDMA levels above the acceptable limit. Beximco Pharmaceuticals said NDMA came to be in their drug from impurity in the raw material.
Beximco said they have tested the local formations of Metformin Hydrochloride Extended Release, but found no anomalies and so have not recalled any drugs from the domestic market. Five Canadian pharmaceutical companies recalled certain metformin drugs as early as June this year. Meanwhile, in December 2019, the European Medical Association concluded that metformin drugs in the European Union have not been affected with NDMA.
However, while the FDA came down on NDMA and Beximco recalled their products internationally, the Directorate General of Drug Administration is yet to decide on the local market, which contains 427 registered formations of Metformin Hydrochloride. We should test all drugs in the market because metformin is a very popular drug for diabetes control. The Drug Administration must test all the medicine that contains NDMA immediately and take decision accordingly.
