Pharmaceuticals are focusing on domestic actions for NDMA

NDMA was detected in 2 of 10 items, all below baseline

The MFDS, "under investigation"

Investigations have shown that Metformin's impurity content is safe in the US and EU.

 

In Korea, the Ministry of Food and Drug Safety has also begun inspections after deriving the test method.

 

The US Food and Drug Administration (FDA) announced on the website that some of the Metformin products sold under the FDA approval and carcinogenic substance 'N-nitrosodimethylamine (NDMA)' was detected, but the daily intake (96 ng) was not exceeded.

 

Of the 10 products examined, NDMA was detected only in six lots of two Metformin 1000mg ER & Metformin 500mg ER products by Actavis.

 

Detection amount was 0.01 ~ 0.02 microgram (mcg) per tablet.

 

NDMA test results of 10 Metformin products conducted by FDA (Source: FDA)

The FDA said that the test did not confirm a sample of Metformin with NDMA detected above the maximum daily intake and currently does not recommend the recovery of Metformin in the United States.

 

In the near future, it will be posted on the website the method for detecting NDMA of Metformin used in the laboratory.

 

On December 6, last year, the European Medicines Agency (EMA) said on its homepage, “There are very few NDMA detected in some Metformin products sold outside of the EU.

 

Metformin products in the European Union have not yet been detected for NDMA detection".

 

In the near future, it is expected that the results of the investigation of Metformin NDMA detection will be released in Korea.

 

The risk of NDMA in metformin was triggered in Singapore.

 

On December 4, last year, the Singapore Health and Science Agency (HSA) surveyed 46 metformin products sold locally, recovering three products and detecting NDMA above the daily allowance.

 

The whole view of the MFDS

The MFDS received data on the use of Metformin from pharmaceutical companies.

 

The MFDS has received data on the production of pharmaceuticals containing Metformin hydrochloride and the systematic investigation of raw materials used until December 17 last year.

 

Pharmaceutical companies submitted the total number of drugs containing Metformin, items and number of production records, items and quantity without production record to the MFDS.

 

The Metformin lineage survey at the MFDS is a preliminary activity to prepare for the detection of impurities.

 

If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company.

 

The MFDS unveiled Metformin's NDMA test on January 15, a month and a half after the Metformin NDMA risks were raised in Singapore.

 

It was suggested to test by Gas Chromatography (GC) method.

 

The industry is alert on the results of Metformin's NDMA inspection in Korea.

 

It is not easy for pharmaceutical companies to test whether they detect Metformin's NDMA.

 

That's because there aren't enough institutions with analyzers to make self-checks.

 

Some pharmaceutical companies are reportedly considering buying their own analyzers.

 

However, it costs ₩300 to 500 million for each analyzer and every year, ₩ tens of millions in management costs are inevitable.

 

Pharmaceutical companies fear that if Metformin is the case, with massive losses in Valsartan and Ranitidine, irreversible losses can occur.

 

Metformin is overwhelmingly larger than Valsartan and Ranitidine.

 

According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion.

 

Ranitidine, which had been suspended from selling all its products, has formed a prescription scale of about ₩200 billion, which is more than double the market.

 

The unit price of Metformin is less than ₩100.

 

That's an overwhelming amount of ranitidine.

 

Outpatient Rx performance of Metformin-containing medicines by year (Unit:₩100 million, Source: UBIST)

Tensions are heightened by pharmaceuticals, as the MFDS has taken tough measures on impurities-detecting drugs.

 

In the case of Valsartan, the MFDS discontinued the sale of drug products that used the ingredients in question at least once in January 2015.

 

Many products are likely to be discontinued even though they did not use the raw materials in question.

 

In the United States, only the products using the Zhejiang Huahai Pharmaceutical raw materials were recovered by manufacturing unit.

 

No action was taken to sell the entire item.

 

In Europe, the measure of action was similar.

 

All ranitidine products have been discontinued in Korea.

 

while in the US and Europe, pharmaceuticals were collected by their own lot numbers.

 

In the case of 13 items of Nizatidine have been discontinued, but some of the products have been recalled in Japan, and no products have been ordered in the United States and Europe.

 

An official from the MFDS said, "We are in the process of inspecting the Metformin NDMA test after deriving it".