Issues on e-cigarette·NDMA were raised again

The MFDS is slowly progressing pending drug administration issues

Research on the dangers of electronic cigarettes and release of Metformin next month

Issues related to medicines that were quiet due to the COVID-19 outbreak were raised again.

 

There are big issues waiting to be investigated, from sampling investigations of Metformin to conducting work on overseas manufacturing plants and publishing results of risk studies of electronic cigarettes.

 

According to the MFDS on the 13th, it recently announced that it has been tested for incorporation of NDMA (N-nitrosodimethylamine), a carcinogen related to Metformin, and will release it soon.

 

#Last year, the MFDS tested the NDMA incorporation by collecting the entire manufacturing lot numbers and the four same ingredients of Nizatidine, which have similar chemical structures, as well as Ranitidine.

 

The MFDS disclosed the test results of 395 items in two weeks after September 14 when the possibility of NDMA impurities of Ranitidine.

 

Metformin, on the other hand, has begun investigations since December last year, but the results have not been released.

 

An official from the Ministry of Food and Drug Administration said, "Metformin may have a different NDMA content depending on the production process’ lot numbers." and he added that the same drug substance also secured a large number of samples for each process and investigated the contents of about 900 samples.

 

" He explained that it took time for a large number of samples and more time to investigate finished products as well as to correct the content variation.

 

He said that the administrative work was paralyzed because of the COVID-19 outbreak, saying that the prosecution had already been completed and that the results would be published soon in the stage of collecting and analyzing the results.

 

The MFDS is planning to calculate the daily allowable dose and the likelihood of carcinogenesis according to the daily dose, based on the results of this survey of Metformin’s NDMA.

 

In March, the MFDS announced that it would convert the current survey of overseas factories into document review due to the global spread of COVID-19.

 

An official from the MFDS said the transition was a temporary measure to ensure that there was no disruption to the domestic medical product approval schedule and supply and demand, and that due diligence in overseas factories, including pharmaceutical production plants in Fukushima, would be restarted after confirming the status of COVID-19.

 

Meanwhile, safety measures for Belviq remain unchanged.

 

In January, the FDA warned of the risk that Belviq would develop cancer, and the MFDS decided to discontinue sales of Belviq in February.

 

The FDA analysis showed that more patients in the Belviq group compared to placebo were diagnosed with cancer in the clinical trials of approximately 12,000 patients for 5 years, but there was a disagreement over statistical significance.

 

This is because primary cancer was diagnosed in 462 (7.7%) out of 5,995 patients receiving Velviq and 423 (7.1%) out of 5,992 patients receiving placebo.

 

Some medical practitioners have judged that the figure is difficult to have statistical significance within the margin of error.

 

Officials from the MFDS said that the suspension and recovery measures were preemptively responded to the unknown cancer controversy rather than the basis for actual judgment.

 

he added that they had obtained and analyzed raw data because it was not possible to verify statistical differences with cancer rates of only 7.7% versus 7.1%.

 

He added that, after reviewing the FDA data, there was no change in the decision and that will remain until further new action, such as the FDA, is taken.

 

On the other hand, the results of the research on the dangers of liquid cigarettes next month are also coming out.

 

The research results on the hazards jointly conducted by seven related ministries, such as the MOHW, have been attracting attention because it can serve as a basis for kicking out liquid electronic cigarettes.

 

The MFDS has been conducting liquid electronic cigarette inhalation and human toxicity studies since June last year by the request of the MOHW.

 

An official from the Ministry of Food and Drug Safety explained that in December last year, we disclosed the results of the investigation of the composition of liquid e-cigarettes.

 

and he also added that the current research is related to the correlation between liquid e-cigarettes and human health.

 

"It took time because the capacity and product container specifications were different between the items and the test method was not established, and the content will be released as early as next month." he said.