COVID-19: FDA Re-emphasizes Importance of Close Patient Supervision for 'Off-Label' Use of Antimalarial Drugs to Mitigate Known Risks |
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COVID-19: FDA Re-emphasizes Importance of Close Patient Supervision for 'Off-Label' Use of Antimalarial Drugs to Mitigate Known Risks

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The U.S. Food and Drug Administration has issued a Drug Safety Communication pertaining to the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, reported with their use in the treatment or prevention of COVID-19, for which they are not approved by the FDA.

These risks, included in the drug labels for their approved uses, may be reduced if healthcare professionals closely screen and monitor these patients such as in a hospital setting or a clinical trial, as mentioned in the Emergency Use Authorization (EUA) for these drugs for the treatment of COVID-19… (FDA, April 24, 2020)

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