The regulator has suspended the sales of 31 metformin-containing diabetes drugs due to possible carcinogen risk on Tuesday, virtually kicking them out of the market.
However, diabetic patients will not have to worry about their medications because physicians can prescribe many other alternatives.
Still, JW Pharmaceutical and Hanall Biopharma are expected to suffer a significant drop in sales of their anti-diabetic drugs, according to the latest industry data.
The Ministry of Food and Drug Safety said it collected all the locally distributed drugs that used metformin as the main ingredient for inspection, and the testing showed that 31 locally made products had N-Nitrosodimethylamine (NDMA), a possible carcinogen, exceeding the permissible level.
The regulator assured the public that the probability of developing cancer because of the metformin intake was only 0.21 out of 100,000. Thus, patients should not discontinue metformin medication arbitrarily without consulting a doctor or a pharmacist, the government said.
However, patients taking the 31 drugs are likely to demand to replace these drugs with others, and doctors are likely to do so. Thus, the 31 medicines will naturally have to leave the market.
The suspension of the sales of the 31 products is expected to damage the revenues of the drugmakers.
JW Pharmaceutical and Hanall Biopharma will be hit hardest, as their annual sales of the metformin recorded several billions of won.
According to UBIST data on prescriptions in 2019, the 31 suspended medicines sold 22.5 billion won ($18.2 million) last year.
Among them, JW Pharmaceutical’s Guardmet Tab. recorded the largest annual sales, selling more than 9 billion won, last year, followed by Hanall Biopharma’s Glucodown OR Tab. with 7.8 billion won. Hutecs’ Gluless-M Tab., Hanmi Pharmaceutical’s Grimefol, Jeil Pharmaceutical’s Lipito-M, and CMG Pharmaceutical’s Amadin sold about 400-700 million won, respectively, last year.
Metformin’s patent expired a long time ago, and the agent is available as hundreds of generic medications. It is as cheap as less than 200 won per tablet and widely used as the first-line medication for diabetic patients.
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