FDA Warns against Unsupervised Use of Chloroquine to Treat Coronavirus

FDA Warns against Unsupervised Use of Chloroquine to Treat Coronavirus

FDA Warns against Unsupervised Use of Chloroquine to Treat Coronavirus

Regulators said they are now investigating unsafe side effects and deaths reported with the malaria drugs to poison control centres and other health authorities.

The U.S. Food and Drug Administration (FDA) on Friday cautioned against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.

"Close supervision is strongly recommended", the FDA said.

Researchers treated 81 COVID-19 patients with the drug between March 23 and April 5 at a medical facility in Brazil.

"They are being studied in clinical trials for COVID-19, and we authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible", the FDA explained in a news release.

Researchers analysed data on 368 United States military veterans from Veterans Health Administration (VA) and found that 28pc of 97 patients given hydroxychloroquine along with standard care died, compared with a death rate of 11pc for the 158 patients who did not receive the drug.

President Donald Trump has touted hydroxychloroquine as a potential coronavirus cure.

The agency said it was aware of increased use of the drugs through outpatient prescriptions as well as reports that they could cause abnormal heart rhythms, often in combination with the antibiotic azithromycin. The FDA has also warned doctors to refrain from prescribing the drugs to treat the coronavirus outside of a hospital. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.

"[The two drugs] taken together, have a real chance to be one of the biggest game-changers in the history of medicine", Mr Trump recently wrote on Twitter.

In fact, the study, conducted in the Brazilian city of Manaus, had hoped to recruit 440 patients, but it was terminated early - with just 81 patients enrolled - when "severe adverse events" linked to chloroquine became apparent. When that time is too long, it can trigger a rhythm problem that can lead to sudden death.

The drug proved to be no better than standard care among more than 300 male patients at Veterans Health Administration medical centers across the nation, according to a report on pre-publication server medRxiv.

Accepting the donation required sign off by both the FDA and the Biomedical Advanced Research and Development Authority, or BARDA, a unit of HHS tasked with procuring treatments to combat bioterrorism and infectious diseases.

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