FDA ok’s patch to monitor patients on hydroxychloroquine for COVID

The Food and Drug Administration is receiving a large number of requests for product approval in connection with the COVID-19 outbreak, and issuing Emergency Use Authorizations as needed.

On Thursday, the FDA issued an EUA for a patch to help them monitor the QT intervals of patients being treated for COVID-19 with drugs that may cause life-threatening heart problems.    The QT interval is  a measurement made on an electrocardiogram used to assess some of the electrical properties of the heart. It is calculated as the time from the start of the Q wave to the end of the T wave, and approximates to the time taken from when the cardiac ventricles start to contract to when they finish relaxing. An abnormally long or abnormally short QT interval is associated with an increased risk of developing abnormal heart rhythms and sudden cardiac death.

On April 24, 2020, the FDA issued a warning about known side effects, heart problems associated with the use of hydroxychloroquine and chloroquine.

The FDA explains on its website that it issued an EUA for the G Medical VSMS ECG Patch intended to be used by health care professionals in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment for COVID-19 with drugs that can prolong QT intervals (measurements used to evaluate some of the electrical properties of the heart) and may cause life-threatening arrhythmias (such as, hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).

The FDA says such remote monitoring may reduce health care professional exposure to SARS-CoV-2, the virus that causes COVID-19.  The health care team will still be able to monitor the patients’ health.    G Medical Innovations Ltd. is a healthcare company based in Israel that specializes in electronic and mobile health devices.

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