BPOM Revokes Use Of Chloroquine For COVID-19 Drugs Because Of Risk

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JAKARTA - The Food and Drug Administration (BPOM) has withdrawn its approval for the use of chloroquine and hydroxychloroquine for the treatment of COVID-19 because it is risky.

"The BPOM has withdrawn the emergency use authorization (EUA) approval for hydroxychloroquine and chloroquine for the treatment of COVID-19," said Head of BPOM Penny K Lukito to reporters in Jakarta, reported by Antara, Thursday, November 19.

At the end of October, BPOM received a safety report on the use of hydroxychloroquine and chloroquine from the results of a four-month observational study in seven hospitals in Indonesia. Of the 213 cases that received hydroxychloroquine or chloroquine, it was found that 28.2 percent had heart rhythm disturbances in the form of prolonged QT interval.

Penny said the BPOM in withdrawing the EUA of the two drugs was based on joint monitoring with a team of experts which was then discussed with health professional organizations, namely PDPI, PERKI, PAPDI, PERDATIN, IDAI and PERDAFK.

BPOM together across sectors, he said, draws the conclusion that the use of chloroquine and hydroxychloroquine in the treatment of COVID-19 has a greater risk than the benefit.

"Thus, drugs containing hydroxychloroquine and chloroquine should no longer be used in the treatment of COVID-19 in Indonesia," he said.

The distribution permit for drugs containing hydroxychloroquine with indications other than COVID-19 treatment, he said, was still valid and could be used for treatment according to the indications approved in the distribution permit.

Meanwhile, for drugs containing chloroquine, he continued, their distribution permit was revoked because they were not used for other indications.

"POM continues to monitor and follow up and update information by communicating with related health professionals based on the latest data in Indonesia, information from WHO and drug regulatory agencies in other countries," he said.

Previously, the United States BPOM (US-FDA) also revoked special licenses for chloroquine and hydroxychloroquine. The World Health Organization (WHO) has also stopped clinical trials of hydroxychloroquine because it is considered to have greater risks than benefits.