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Beximco says the problem is not in drug manufacturing. The raw material of the medicine or the preparation process is more likely to have problems. And the raw material of metformin is collected from different producers. The matter is now being closely monitored.
The 500 mg and 650 mg prolonged-release metformin hydrochloride tablets used to control blood sugar in patients with type 2 diabetes are purchased from Beximco Pharmaceuticals and sold by Beshor Pharmaceuticals in the United States.
The two recalled tablet lots have been found to contain more than acceptable levels of a substance called N-nitrosodimethylamine (NDMA), which poses a potential risk of causing cancer in the human body, according to the Food and Drug Administration of the United States (FDA).
The FDA said Aug. 19 that the company recalled two batches of the two Beximco drugs on Aug. 19 last year.
An FDA warning said the presence of NDMA in those two batches was above the acceptable daily level and Besho announced the voluntary recall of the drug from the market.
However, the FDA recommends that patients continue to use metformin hydrochloride ER until an alternative drug or treatment is prescribed by a doctor or pharmacist.
He also called on physicians and healthcare professionals to continue to counsel patients on the use of metformin hydrochloride ER if it is clinically appropriate.
Based on the results of laboratory studies, NDMA is classified as a potential carcinogen in the human body. NDMA, which is well known as an environmental pollutant, is found in food and dairy products, including water and meat, and in vegetables.
According to FDA standards, taking NDMA up to 098 decimal micrograms or 96 nanograms per day does not harm the human body.
The FDA recommended that many pharmaceuticals be recalled, citing the presence of an excessive presence of NDMA when testing lot number 1657 of the 650 mg metformin hydrochloride ER tablet.
As a precautionary measure, eight batches of metformin hydrochloride ER tablets made with the same raw material were tested and many of the batches mentioned above and 16001 batches of 500 mg tablets were recalled due to acceptable excess of NDMA. .
However, Beshor or Beximco did not receive any reports of adverse reactions to the use of the drug.
In June 2015, Beximco Pharmaceuticals became the first Bangladeshi pharmaceutical company to be approved for export to the United States and on December 13, 2016, the company was approved to export Metformin Hydrochloride-ER tablets as its third drug.
Rabbur Reza, COO of Beximco Pharmaceuticals, told bdnews24.com in an email: Beximco started the trial.
“We get a little more NDMA than the standard set by the FDA in the two batches. We immediately notify the FDA and supplier partner Besho Pharmaceuticals. The two lots were withdrawn from the market in the United States on August 19.
Regarding the excessive presence of NDMA in medicine, the rabbi said: “Our scientists have confirmed that the problem is not related to the manufacture of the drug, but to the raw material of the drug or its manufacture. We do not manufacture metformin raw materials ourselves, we collect from different manufacturers.
“Since June, I have been urging my manufacturers to declare the level of NDMA in every batch of raw material purchased. After the purchase, I am testing the level of NDM in the raw material of each batch in my own laboratory and the drug is being tested even before it is finally released on the market. “
Although the NDMA test is not required by the FDA, Beximco is doing it on its own initiative for the safety of consumers, the official said.
When asked about this, Ayub Hossain, Deputy Director of the Department of Drug Administration, told bdnews24.com that Bangladesh was aware of the excessive presence of NDM in the extended release (ER) of metformin hydrochloride.
For this, samples were taken from 19 companies. I am preparing to send it to a laboratory in Singapore for analysis. If that lab in Singapore accepts us, we’ll send the sample there. “
(Lead correspondent Obaidur Masum and correspondent Farhan Ferdous himself helped compile the report.)
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