Discontinuation of Anti-Inflammatory

Discontinuation of Anti-Inflammatory

On the 23rd of March, the Central Pharmaceutical Affairs Council has decided to discontinue the sales of Serratiopeptidase related products.

Serratiopeptidase is known to be used as an anti-inflammatory and expectorant, however on 24th of March the Korean Food and Drug Administration (KFDA) has announced that there is no proven efficacy.

There are 95 products currently available in the market. The KFDA has distributed the news regarding the discontinuation of the prescription and use, and has advised to return the related products.

Currently in Japan, the Takeda Pharmaceutical Company has conducted the post-marketing trial and has failed to show the efficacy of Serratiopeptidase thus asked for voluntary recall and discontinue the sale.

The KFDA has stated “the validity and the level of the clinical trial data submitted by the manufacturer, and the reviews from the Central Pharmaceutical Advisory Committee, was not enough to justify the efficacy “.

Meanwhile, Serratiopeptidase has been authorized in countries such as Germany, Italy, Taiwan, and some Southeast Asian countries and has produced 90 billion based on year 2009 results.