Drug safety ministry in hot seat over remdesivir approval despite side effects

30-Sep-2020 Intellasia | KoreaTimes | 6:02 AM Print This Post

Suspicions have been raised that the Ministry of Food and Drug Safety granted conditional permission for anti-viral drug remdesivir to be used as a COVID-19 treatment, despite having received a report about side effects.

According to data submitted to Rep. Kang Gi-yoon of the People Power Party, Tuesday, the report on Phase 3 clinical trials conducted by Seoul Medical centre from March 27 to June 25 included possible side effects such as a lowered heart rate. Although the report was submitted to the drug safety ministry in April, the ministry granted authorisation for remedesivir to be marketed as a coronavirus treatment July 24.

The ministry said it was a conditional authorisation and Gilead is still required to submit the final results of international clinical trials, data on manufacturing and quality control standards, and additional risk mitigation measures after marketing.

Unlike special imports, marketing authorisation indicates that considerable safety and effectiveness trials have been carried out on a substance, even though some tests results need to be checked and analysed further.

Remdesivir is an antiviral drug developed by Gilead Science as an Ebola treatment. Clinical tests conducted by 73 medical institutions in 10 countries around the world led by the National Institutes of Health (NIH) in the United States drew attention as the drug reduced the recovery period for some COVID-19 patients by 31 percent from 15 days to 11 days.

The government has allowed the special import of the drug for emergency use since June in a bid to make it easier to secure an adequate supply of the medicine.

Last month, quarantine authorities confirmed some adverse reactions in a COVID-19 patient who was administered remdesivir. They included increased liver enzyme levels, a skin rash, and a slight premature contraction of the ventricles in the heart.

According to the ministry, 274 coronavirus patients had been administered the drug as of September 7.

“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 fact that the country is in a severe crisis due to coronavirus,” Rep. Kang said.



Category: Korea

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