Published 06:27 IST, June 19th 2020
US left with 63 million doses of anti-malarial drug HCQ after FDA ban
According to the reports, the FDA also revoked its authorisation of the use of chloroquine phosphate (CP) earlier this week.
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The United States government is now left with 63 million doses of hydroxychloroquine sulfate (HCQ) after the Food and Drug Administration (FDA) withdrew its permission for the use of the anti-malarial drug in treating the COVID-19 patients.
According to the reports, the FDA also revoked its authorisation of the use of chloroquine phosphate (CP) earlier this week which is also being used to treat the novel coronavirus disease.
HCQ and CQ not effective: FDA
The FDA has reportedly concluded that HCQ and CQ are not effective in treating COVID-19 patients. The US drug authorisation body, in a statement, noted that the anti-malarial drug has severe side effects on COVID-19 patients and thus must be withdrawn from treatment. The US government had started stocking HCQ in late March specifically for the treatment of COVID-19 patients.
United States revokes first antibody
Meanwhile, the FDA on June 16 revoked the use of one of the first antibody tests it authorised during the coronavirus public health emergency. The FDA in a release on Tuesday said that it is revoking the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) antibody test due to performance concerns with the accuracy of the test. Antibody tests are a type of serological test that helps in providing information about a person's or a population's COVID-19 exposure.
According to FDA, data submitted by Chembio as well as an independent evaluation of the Chembio test at the National Cancer Institute (NCI) showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorised labeling for the device.
The FDA further said that the revocation of the Chembio test is appropriate because it puts the health and safety of the American public at risk from false results.
Image: PTI
06:27 IST, June 19th 2020