Suspicion was raised that the Ministry of Food and Drug Safety had conditionally approved it as a treatment even though it was aware of the side effects of remdesivir, a treatment for COVID-19.



According to the data received from the Ministry of Food and Drug Safety, Rep. Kang Ki-yoon, a member of the National Assembly Health and Welfare Committee, the Ministry of Food and Drug Safety has a side effect of'heart rate reduction' occurring in phase 3 clinical trial of remdesivir conducted from March 27 to June 25 at the Seoul Medical Center. One case was reported in April, but the treatment was approved on July 24th.



Domestic remdesivir permits are conditional.



At that time, the Ministry of Food and Drug Safety said it had decided based on the literature data of the preclinical trial and the results of interim analysis of the clinical trial.



Conditional approval is based on the condition of submitting the final results of international clinical trials, some manufacturing and quality control standard data, and additional risk mitigation measures after marketing.



Remdesivir is an antiviral drug developed by Gilead Sciences as a treatment for Ebola.



In clinical trials conducted in 73 medical institutions in 10 countries and 10 countries, led by the National Institute of Health (NIH), the effect of reducing the recovery period of COVID-19 patients by about 31% from 15 days to 11 days received attention.



In August, the quarantine authorities confirmed adverse reactions in COVID-19 patients who were given remdesivir.



These include elevated liver levels, skin hives and rashes, and premature heart ventricular contractions.



According to the quarantine authorities, a total of 274 Corona19 patients received remdesivir as of the 7th of this month.



Rep. Kang Ki-yoon said, "There is no drug that does not have side effects, but if a side effect occurs in a domestic clinical trial, it should have been transparently disclosed in consideration of the reality that the entire public is in a severe crisis due to Corona 19."



(Photo = Yonhap News)