COVID-19: Why FDA cancels authorisation for Chloroquine, Hydroxychloroquine

* Medicines have become increasingly politicised by Trump and Administration officials ─FDA  

* A number of clinical trials evaluating drugs have failed

Isola Moses | ConsumerConnect

The United States Food and Drug Administration (FDA) has said it has withdrawn the emergency use authorisation (EUA) granted to Hydroxychloroquine and Chloroquine during the COVID-19 pandemic.

According to the agency, an EUA is not the same as a FDA approval, but is a type of authorisation that can be awarded during public health emergencies when there are no other available treatment options, says agency report.

The federal agency, report stated, had issued the EUA in March 2020, allowing some patients with COVID-19 to be treated with the drugs when used from a federal stockpile.

However, it was learnt that the drugs have become increasingly politicised, following promotion from Trump Administration officials, including President Donald Trump himself, and have faced questions about their clinical usefulness and potential safety risks.

Likewise, a number of clinical trials evaluating the drugs have failed, and the emerging scientific consensus has indicated that the drugs, which are approved to treat lupus, malaria, and rheumatoid arthritis, do not benefit patients with COVID-19 and may cause additional health risks, says Reuters.

The messaging around Hydroxychloroquine has been further complicated by an inaccurate study that found the drugs harmed patients. That research was later retracted by The Lancet, a prestigious medical journal.

He report added that the letter revoking the EUA is addressed to an official at the Biomedical Advanced Research and Development Authority.

Recall that since June 5, 2020, report had indicated that the drugs were said to have faced steady scientific and political scrutiny over whether they could in fact help treat or prevent infections with the ravaging Coronavirus.

A month ago, about 70 percent of the COVID-19 patients being treated at the 13 hospitals that make up the Hackensack Meridian Health system in New Jersey, United States, received Hydroxychloroquine as part of their care. That’s no longer the case.

Clinicians and hospital administrators made that decision following a series of clinical studies including internal research published May 27 as a preprint that found the drug, long used as an antimalarial treatment, does not improve outcomes in hospitalised COVID-19 patients, according to Dr. Stuart Goldberg, a physician at Hackensack University Medical Center.