Doctors can still prescribe anti-malarial drug hydroxychloroquine to patients, US Health Secretary Alex Azar said, hours after the FDA withdrew the emergency use authorisation of chloroquine and HCQ in the treatment of COVID 19 patients. The US Food and Drug Administration's (FDA) decision came on Monday after it concluded that the anti-malarial drugs may not be effective to cure the virus infections and lead to greater risks than any potential benefits.
"At this point, hydroxychloroquine (HCQ) and chloroquine are just like any other approved drug in the United States. They may be used in hospital, they may be used in out-patient, they may be used at home, all subject to a doctor's prescription," Azar said. "In fact, the FDA's removal of the Emergency Use Authorization takes away what had been a significant misunderstanding by many that had made people think that somehow it could only be used in a hospital setting, and we've tried to make that clear throughout," he said in response to a question.
During a White House media appearance with President Donald Trump, Azar asserted that HCQ was approved in the United States. "If a doctor wishes to prescribe it, working with a patient, they may prescribe it for any purpose that they wish to do so. And, this (FDA's decision) actually removes a potential barrier to them," the health secretary said.
The FDA said its decision in this regard was based on new information, including clinical trial data results, that have led it conclude that the drugs may not be effective in treating COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks. FDA chief scientist Denise Hinton, in a letter dated June 15 to Gary Disbrow of Biomedical Advanced Research and Development Authority (BARDA), said as of the date of this letter, the oral formulations of hydroxychloroquine (HCQ) and (chloroquine) CQ are no longer authorised by the FDA to treat COVID-19. On March 28, FDA had issued emergency use authorization (EUA) for use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS).
Hinton said that FDA now believes that the suggested dosing regimens for CQ and HCQ are unlikely to produce an antiviral effect. "Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomised controlled trial assessing probability of negative conversion showed no difference between HCQ and standard of care alone," he said.
Current US treatment guidelines do not recommend the use of CQ or HCQ in hospitalised patients with COVID-19 outside of a clinical trial, and the NIH guidelines now recommend against such use outside of a clinical trial, the FDA said. Azar described the media interpretation of FDA's letter as inaccurate.
"With the FDA finding that they don't see enough data to support hospital-based use, for those who are the most extreme cases of patients who have been hospitalised, they took that restriction off. They took the Emergency Use Authorization off," he said. Azar asserted that FDA said its data in the hospital setting was not supportive. "We continue to study in out-patient settings, as well as preventative. That data is not yet in," he added.
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