Saturday, 25 April 2020

FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

U.S. Food and Drug Administration issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.



source https://www.pharmatutor.org/pharma-news/2020/fda-reiterates-importance-of-close-patient-supervision-for-off-label-use-of-antimalarial-drugs-to-mitigate-known-risks-including-heart-rhythm-problems

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