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The Food and Drug Administration warned consumers Friday against taking malaria drugs chloroquine and hydroxychloroquine to treat Covid-19 outside a hospital or formal clinical trial setting after deaths and poisonings were reported.

The agency said patients taking the drugs for approved reasons, including malaria or to treat autoimmune conditions like lupus, should continue taking their medicine as prescribed.


The agency also said it became aware of reports of "serious heart rhythm problems" in patients with the virus who were treated with the malaria drugs, often in combination with antibiotic azithromycin, commonly known as a Z-Pak. It also warned physicians against prescribing the drugs to treat the coronavirus outside of a hospital.

"Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia," the agency wrote in the notice. "We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information."

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The FDA rescinded its emergency use authorization (EUA) of hydroxychloroquine (HCQ) to treat COVID-19 patients, citing concerns about efficacy and risks associated with its use, and saying the drug no longer meets the criteria for an EUA, the agency said on Monday.

A brief paragraph at the bottom of the FDA's emergency use authorization page noted that the FDA has determined that based on continued review, the "statutory criteria" for an emergency use authorization are no longer met. The agency went on to say both hydroxychloroquine a related antimalarial drug, chloroquine (CQ), are "unlikely to be effective at treating COVID-19" for uses described in the EUA.

Moreover, the FDA now says the benefits of the drug "no longer outweigh the potential risks," citing the serious cardiac adverse events associated with the drug.

"This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19," the agency said.

A letter from the agency to the Biomedical Advanced Research and Development Authority (BARDA) detailed the FDA's concerns, including that suggested dosing regimens are "unlikely to produce an antiviral effect," and said "decreased viral shedding" from treatment with these drugs, noted in some observational studies, "has not been consistently replicated."

While current FDA guidelines did not recommend use of the drugs outside of a randomized clinical trial, the FDA also pointed to recent data from a large clinical trial showing no "evidence of benefit" for mortality, effect on hospital length of stay, or need for mechanical ventilation among COVID-19 patients treated with hydroxychloroquine.

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Early treatment with hydroxychloroquine cut the death rate significantly in certain sick patients hospitalized with COVID-19 — and without heart-related side effects, according to a new study published by Henry Ford Health System.

The study, published Thursday in the International Journal of Infectious Diseases, is another curve in the continued research — and its sometimes conflicting results — into whether a drug that seemed promising at the beginning of the COVID-19 pandemic really works.

The Henry Ford study examined outcomes of 2,541 patients hospitalized with COVID-19 between March 10 and May 2 across the Michigan system’s six hospitals. Overall, 18% of the patients died in the hospital.

But there were marked differences in their treatment.

Among those who received hydroxychloroquine as part of early treatment, 13% died, compared with 26% of those who did not receive the drug.

Mortality among all patients was highest among those who were older than 65, white, and were admitted with already-reduced oxygen levels. They also commonly had serious underlying diseases, including chronic kidney and lung disease.

Dr. Marcus Zervos, head of infectious disease at Henry Ford Health System, acknowledged that Henry Ford’s results differ from other studies.

“There’s variability in the literature on outcomes with hydroxychloroquine ... What we think was important in our study was our patients were treated early. And for hydroxychloroquine to have a benefit, it needs to be given before the patient suffers some of the severe immune reaction that can occur with COVID.”

That’s because the drug works by inhibiting the immune system’s inflammatory response to the virus, Zervos said.

Patients were monitored for possible heart issues, he added, and anyone who was at risk for cardiac abnormalities was excluded from the study.

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The World Health Organization (WHO) announced Saturday it is halting its trials of the malaria drug hydroxychloroquine and HIV treatment lopinavir/ritonavir in patients hospitalized with the coronavirus after results showed the drugs did not reduce mortality rates."These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect," the WHO said in a statement, referencing multi-country trials it is conducting.