Metformin a drug used to treat Diabetes recalled due to the presence of cancer causing agent

Metformin, (trade name Glucophage) a popular drug used to treat Type II diabetes is found to have contained a trace amount of a cancer-causing agent (a carcinogen) called N- nitrosodimethylamin (NDMA) [1]. This compound is a semi-volatile organic chemical which has been considered as a probable carcinogenic to humans.

The health authorities worldwide are also considering to take further action against all such products which could have the above-mentioned cancer-causing agent. Although it is reported that the carcinogenic agent if available in very low quantity is not harmful because people are exposed to if from other sources (water etc) also. But if its concentration in any consumable item including the medicine is above the acceptable range then it could be extremely dangerous for human beings.

Metformin recalled from the market in Singapore due to the possibility of having a cancer-causing agent.

In Singapore, after the warning issued by the FDA, products containing Metformin has been recalled from the market. These products are now under the process of testing to confirm the presence of carcinogenic impurities in it. The higher health authorities may also take further actions in this regard.

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In European Union countries instructions have also been issued to the concerned pharma industry to test all the suspected products and the latest information regarding the safety and usability of the products should be provided.

The food and Drug admiration (FDA) has issued warnings about the issue in the first week of December 2019 after which fear has been generated throughout the world about the safety of the product.

The people are also advised not to be panic because the product has been recalled as a precautionary measure and the concentration of NMDA in the product may be within the permissible limits.

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The presence of N-Nitrosodimethylamin or NDMA, a cancer-causing agent in different items of daily use.

The carcinogenic agent N-Nitrosodimethylamin or NDMA can be found in drinking water and other food items of daily use. It is the bye product of certain pesticides, various industrial process (tanneries, rubber, tire manufacturing plants), water-waste discharges and can also be obtained from rocket fuel [2].

This compound can also be found at water treatment plants which use chloramines for the disinfection.  Its regulatory limit in drinking water has been established at 0.1 micrograms per litre (0.0001mg/ lit). Consuming 0.096 µg (microgram) of NDAM/day is considered safe for human.

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The cancer-causing ability of NDMA has been proved scientifically in experimental animals when this compound was given to them by various routes including drinking water [3].

About 2 years ago some other products were also recalled from the market due to the presence of NDMA in it. The products included Ranitidine (used in heartburns) and losartan, valsartan, irbesartan (used in blood pressure).

Ranitidine is used as an over the counter drug (OTC). It was the product of Sanofi having a trading name Zantac. Similarly, valsartan was available in the market with a trading name of Diovan, made by Novartis.

Both these medicines were in common use throughout the world for several years but their production was halted when FDA issued warning against them.  Their manufacturers and distributors stopped their production and distribution respectively. The products available in the market were recalled to avoid any damage to consumers.

The sudden and large-scale withdrawal of valsartan has led to the shortage of medicine and the patients were at risk. While keeping an eye on the situation and to avoid inconvenience, the FDA had granted fast track approval of a new generic of valsartan to effectively cope with the situation and to provide relief to the public.

References

  1. Zeng T, Mitch WA. Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Carcinogenesis. 2016;37(6):625-34.
  2. Sun Y, Angelotti B, Brooks M, Dowbiggin B, Evans PJ, Devins B, et al. A pilot-scale investigation of disinfection by-product precursors and trace organic removal mechanisms in ozone-biologically activated carbon treatment for potable reuse. Chemosphere. 2018;210:539-49.
  3. Mendoza AL. Photocatalytic Oxidation of N-Nitrosodimethylamine by UV-LED Light. 2015.

 

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