COVID-19: European Medicines Agency issues reminder of risk of serious side effects with chloroquine and hydroxychloroquine

News Category: Regulatory news

Date: 23/04/2020

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.

The COVID-19 EMA pandemic Task Force (COVID-ETF) has published a public health statement in consultation with the EMA’s safety Committee (PRAC), in light of the ongoing discussions on the use of chloroquine and hydroxychloroquine in the treatment of COVID-19.

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.

These medicines are being used in the context of the ongoing pandemic for treating patients and are being 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. They should carefully consider the possibility of side effects, particularly with higher doses, and exercise extra caution when combining treatment with other medicines such as azithromycin that may cause similar side effects on the heart.

Further information is available on the EMA website.

The EMA and the national competent authorities are monitoring the situation closely and have enhanced their safety monitoring of medicines used in the treatment of COVID-19 in order to take timely action when necessary. The European regulatory network is committed to providing available information to help healthcare professionals and their patients make informed decisions while awaiting clinical trial data on whether the medicines have a positive benefit-risk balance in the treatment of COVID-19.

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