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The agency is advising healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine for potential side effects.
The European Medicines Agency (EMA) cautioned healthcare providers on May 29, 2020 to closely monitor COVID-19 patients who are also taking chloroquine or hydroxychloroquine for potential side effects including cardiac arrhythmias, cardiac arrest, and neuropsychiatric disorders, and may also affect the liver, cause neuronal damage, and lower blood sugar.
The agency advices that pre-existing heart conditions, uncorrected potassium, or magnesium imbalance should be considered when treating COVID-19 patients with chloroquine or hydroxychloroquine. EMA states that “that heart rhythm disorders may be more likely or be more severe if chloroquine or hydroxychloroquine are used at higher doses than those recommended for their authorized indications or if they are combined with certain antibiotics such as azithromycin.”
Chloroquine or hydroxychloroquine are authorized to treat malaria and some autoimmune diseases and are being used to treat some COVID-19 patients, but the agency warns “their beneficial effects in this patient population are not established.” According to EMA, some countries in the European Union have suspended or stopped clinical trials investigating the use of these drugs for COVID-19 patients.
“EMA reiterates that while further analyses of available data are being carried out, chloroquine and hydroxychloroquine should only be used in clinical trials for treatment or prophylaxis of COVID-19 or in national emergency use programs in hospitalized patients under close supervision. It is important that properly designed, randomized clinical trials can be completed, with adjustments as needed, to generate the necessary evidence on benefits and risks of these medicines in COVID-19.”