A man undergoes medical checkup to qualify as volunteer for clinical trial of a vaccine against Covid-19 at a Padjadjaran University clinic in Bandung, West Java on Aug. 14, 2020. (Beritasatu Photo/Adi Marsiela)
BPOM Revokes Chloroquine, Hydroxychloroquine Authorization for Covid-19 Patient Treatment
BY :JAKARTA GLOBE
NOVEMBER 20, 2020
Jakarta. Indonesia's drug supervisory body has revoked the authorization for chloroquine phosphate and hydroxychloroquine sulfate use in the Covid-19 patient treatment after a study suggesting the drugs increase the risk for heart rhythm disorders among the patients.
On Thursday, the Food and Drug Control Agency (BPOM) said that it had concluded a four-month study in seven hospitals in Indonesia. Of the 213 patients who received these drugs, 28.2 percent experienced heart rhythm disorders.
"Thus, drugs containing hydroxychloroquine and chloroquine should no longer be used in the treatment of Covid-19," BPOM Head Penny Lukito said as quoted by Antara news agency.
Penny said the authorization for treatment other than Covid-19 was still valid. Chloroquine phosphate and hydroxychloroquine sulfate are commonly used to treat malaria, which causes around 6,500 deaths annually in Indonesia.
Indonesia's decision came five months after the United States' Food and Drug Administration (FDA) revoked the emergency use authorization for chloroquine and hydroxychloroquine. The agency said in a statement in June that the drugs were "unlikely to be effective in treating Covid-19," and based on serious cardiac adverse events, the benefits of the drug "no longer outweigh the known and potential risks for the authorized use."
The World Health Organization (WHO) has also cautioned against the drugs and dropped them from its Covid treatments studies in June.
Indonesia started to work on the study to determine the drug's effectiveness and risks, Penny said. Indonesia has bought 3 million doses of
"We continue to monitor and communicate with health professionals regarding the latest data and information from the WHO and drug authorities in other countries," said Penny.
In March, when the number of Covid-19 deaths was still below 150, the government bought 3 million doses of chloroquine phosphate and hydroxychloroquine sulfate in anticipation of spikes in the number of Covid-19 patients.
Since then, Indonesia has seen the number of Covid-19 cases increased to more than 483,000 cases, and 15,600 people died from the pandemic.