South Korea recovered Sartan products with AZBT impurities

Three Irbesartan containing products manufactured before 2021, the drug manufactured before 2021 began to be recovered

Recalls are also being carried out in Europe, including the U.K. and Spain, and test results are imminent

The recovery of Sartan medicines containing 'AZBT' has also begun in Korea.

 

Three products containing Irbesartan, manufactured in 2021, were voluntarily recovered by related pharmaceutical companies.

 

Starting in Canada in May, recovery of Sartan containing AZBT is spreading around the world to Europe and Asia.

 

The MFDS announced on the 6th that it would voluntarily collect three Irbesartan-containing items (Rovelito, CoAprovel, and Aprovel) manufactured before 2021.

 

Sanofi, which supplies Irbesartan in Korea, pre-emptively delivered to distributors and vendors that it would voluntarily recover Irbesartan products produced before January 2021.

 

Sanofi explained why the impurity (AZBT) produced since January 2021 is managed below the acceptable limit, but the previous manufactured batch of finished products was recovered because it needed time to derive test results.

 

The recovery of Sanofi is due to the imminent submission of test results ordered by the Ministry of Food and Drug Safety.

 

Also, the fact that recovery began in Europe affected it.

 

Azido methyl bipheny Tetrazole (AZBT) is a genetic mutation that is believed to occur in the synthesis process of Sartans, a treatment for hypertension.

 

It is different from the carcinogen NDMA detected in Valsartan in 2018.

 

Valsartan has been temporarily recovered and stopped selling all items due to NDMA detection.

 

In the following year, drugs containing Ranitidine were also banned from selling or recovered from NDMA.

 

The AZBT issue began at the end of May when Canada's Federal Health Department voluntarily recalled three ingredients of drug products from nine pharmaceutical companies, including Teva and Sandoz, including Losartan, Valsartan, and Irvesartan.

 

Since then, Korea's Ministry of Food and Drug Safety has also requested the AZBT impurity evaluation and test results to be submitted by the 14th of the month at medicines containing Losartan, Valsartan, and Irbesartan ingredients in early June, and the AZBT test results for all finished product lot numbers by the 31st of the month.

 

This recovery in Korea has been confirmed in a test inspection of finished products since January 2021, but it seems that it was carried out preemptively because the test results did not secure the time of submission.

 

It also appears that recalls of some products containing Losartan, Valsartan and Irbesartan began in some European countries, including the United Kingdom and Spain, last month.

 

Industries are paying attention to the rest of South Korea's generic items that will be affected by the recovery of the original products.

 

Currently, there are 55 products containing Irbesartan licensed in Korea.

 

Also, not only Irbesartan but also Losartan and Valsartan are eligible for recall.

 

This is because not only Canada but also Europe contained all three ingredients.

 

The key is whether to secure the test results.

 

In addition to Irbesartan, many prescriptions from Valsartan and Losartan are expected to cause inconvenience to pharmaceutical companies and medical institutions.

 

However, foreign authorities that conduct recovery recommend not to stop administration of patients, saying that only some lot numbers are recovered and the impact on the human body is unknown.