Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.
In the recent Drug Safety Communication, the FDA emphasized on the importance of close patient supervision for “Off-Label” use of antimalarial drugs to mitigate the known risks.
The FDA said clinical trials are ongoing to determine the safety and effectiveness of these antimalarial drugs for COVID-19.
The regulator encourages health care professionals making individual patient decisions to closely screen and monitor those patients to help mitigate these risks.
EUA is generally issued to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by Chemical, Biological, Radiological and Nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives.
On March 29, the FDA issued an EUA to allow anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile (SNS) as possible treatments for coronavirus (COVID-19) patients. This is the first EUA for a drug related to the COVID-19 response.
These were donated by Sandoz, the Novartis generics and biosimilars division, and Bayer Pharmaceuticals to treat hospitalized adolescent and adult patients with COVID-19 or for use in clinical trials.
The donated drugs are approved by the FDA to treat malaria and other diseases, but not for the treatment of the coronavirus. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.
Reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.
A study in France seemed to suggest that hydroxychloroquine, combined with azithromycin, could work as a treatment for COVID-19.
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