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From the regulator: EMA cautions on drugs taken for Covid-19

| Updated on April 25, 2020 Published on April 25, 2020

Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart, says the European Medicines Agency (EMA).

Recent studies have reported serious, in some cases fatal, heart rhythm problems with chloroquine or hydroxychloroquine, particularly when taken at high doses or in combination with the antibiotic azithromycin.

Chloroquine and hydroxychloroquine are currently authorised for treating malaria and certain autoimmune diseases. In addition to side effects affecting the heart, they are known to potentially cause liver and kidney problems, nerve cell damage that can lead to seizures (fits) and low blood sugar (hypoglycaemia).

These medicines are being used in the context of the ongoing pandemic for treating patients with Covid-19 and investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in Covid-19 have not been demonstrated. Results from large, well-designed studies are needed to make any conclusions.

Some clinical trials currently investigating the effectiveness of chloroquine or hydroxychloroquine in treating Covid-19 use higher doses than those recommended for the authorised indications. While serious side effects can occur with recommended doses, higher doses can increase the risk of these side effects, including abnormal electrical activity that affects the heart rhythm (QT-prolongation).

Healthcare professionals are recommended to closely monitor patients with Covid-19 receiving chloroquine or hydroxychloroquine and to take into account pre-existing heart problems that can make patients more prone to heart rhythm issues. A number of large, randomised clinical trials are looking at the benefits and risks of chloroquine and hydroxychloroquine in patients with Covid-19.

In the context of Covid-19, these medicines should only be used as part of clinical trials or in line with nationally agreed protocols. They must not be used without a prescription and without supervision by a doctor.

This EMA public health statement has been issued by the COVID-19 EMA pandemic Task Force (COVID-ETF) in consultation with EMA’s safety Committee (PRAC), in light of the ongoing discussions on the use of chloroquine and hydroxychloroquine in the treatment of Covid-19, the agency said.

Published on April 25, 2020

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