On Monday (15 June), the US Food and Drug Administration (FDA) withdrew the emergency use of the anti-malarial medicine Hydroxychloroquine for COVID-19-patients, which was referred to as a ‘game changers.’
Based on new information, including clinical trials, the US food, and drug regulatory body has taken the decision. The US FDA also stated that HCQ does not outweigh its known risks in treating COVID-19 patients.
A letter to the Biomedical Advanced Investigation and Development Authority (BARDA) has been written by FDA lead scientist Denise Hinton suggesting that hydroxychloroquine (HCQ) and (chloroquine) oral formulations should not be used in patients with COVID-19.
It is worth recalling that on 28 March the US FDA released an emergency usage authorization on the use of oral chloroquine phosphate formulations (CQ) and hydroxychloroquine sulfate (HCQ).
The letter said, Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing the probability of negative conversion showed no difference between HCQ and standard of care alone.
In particular, the use of CQ or HCQ in hospitalized patients with COVID-19 outside of a clinical trial is not recommended in accordance with current treatment guidelines in the US.
“Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID-19,” the letter said.
Earlier, President Trump had called HCQ a “game-changer” drug, and India allowed for 50 million HCQ tablets to be exported to the United States at his request in April.
At a press conference on 18 May, Trump said he used hydroxychloroquine to be protected from coronavirus every day. Hydroxychloroquine was also called a “defense line” against coronavirus.