Diabetes pills manufactured by Beximco Pharmaceuticals have been recalled in the United States after the Federal Drug Administration (FDA) detected a “probable human carcinogen” in the tablets.
The Bangladesh company had manufactured the Metformin Hydrochloride Extended-Release Tablets in June 2019 and supplied them in eight “lots” to the US company Bayshore Pharmaceuticals.
Beximco Pharmaceutical is part of the Beximco Group, one of the country’s largest conglomerates, whose vice-chairman is the highly influential Salman Fazlur Rahman a member of parliament who serves as the private sector industry and investment adviser to the prime minister, holding the rank of cabinet minister. Its managing director is also the ruling Awami League parliamentarian, Nazmul Hassan.
According to a statement published on the FDA website tests undertaken by the US government regulatory body on one of the eight lots manufactured by Beximco had detected levels of the chemical N-Nitrosodimethylamine – known as NDMA – “in excess of the Acceptable Daily Intake Limit recommended recall.”
NDMA is classified as a probable human carcinogen – that is to say a substance that could cause cancer. It is also known as an environmental contaminant.
On being informed of the contamination, the FDA statement says that Bayshore undertook further tests and detected NDMA in another one of the eight lots of that had been supplied to them by Beximco. The US company agreed to recall both lots of tablets.
The statement added that “neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.”
Earlier in the year, the FDA recommended that six other US based companies recall their metformin products.
Beximco manufactures a number of other products for Bayshore, including the high blood pressure drugs Carvedilol and Nadolol, the antihistamine, Cyproheptadine, and the muscle relaxer Methocarbamal.
On May 4th 2020, the Bangladesh government’s Directorate General of Drug Administration granted an Emergency Use Authorization to Beximco Pharmaceutical to manufacture the anti-viral drug remdesivir IV injection (under the brand name Bemsivir) becoming the first company in the world to launch a generic version. of remdesivir for the treatment of COVID-19.
The Bangladesh pharmaceutical company also recently signed an agreement with the Serum Institute of India (SII) to become the exclusive supplier of any new vaccine against Covid-19 which they manufacture. SII has partnered with AstraZeneca, the Gates Foundation and the Gavi vaccine alliance to produce more than a billion doses of a COVID-19 vaccine for global supply.
Beximco told Netra News that “Ensuring patient safety is our number one priority.”
It said that its “scientists have confirmed that the problem was not related to our formulation or manufacturing process” but from the Metformin API which they had purchased from another supplier. It said that they now use Metformin API made by a different manufacturer and test for NDMA levels.
“We are fully aware of FDA issues with any product anywhere in the world and follow their recommendations and advice accordingly.”
//David Bergman