EMA clarifies use of chloroquine and hydroxychloroquine for COVID-19

Chloroquine and hydroxychloroquine must only be used for COVID-19 in clinical trials or national emergency use programmes in COVID-19 patients whose condition is critical, says the European Medicines Agency, EMA.

In the search for COVID-19 treatments, several types of medicines are investigated and tested in clinical trials all over the world – among them the two medicines chloroquine and hydroxychloroquine, which are currently only authorised for malaria and certain autoimmune diseases. However, the efficacy of these medicines in COVID-19 treatment has not yet been shown in any studies.

For this reason, the EMA has emphasised in an announcement to only use these products in clinical trials or national emergency use programmes for the treatment of COVID-19 patients whose condition is critical.

Chloroquine and hydroxychloroquine are vital medicines for patients with autoimmune conditions such as lupus, which is a chronic condition. It is important these patients can still get their medicines and that no shortages occur due to stockpiling or because the medicines are prescribed off-label, i.e. for other diseases than those they are approved for.

This was the very reason that the Danish Medicines Agency introduced restrictions on prescribing of all medicines containing hydroxychloroquine on 22 March.

Large clinical trials to get enough evidence

Hundreds of trials are being conducted worldwide to obtain the robust data needed to document if medicines already authorised for other diseases could have an effect on COVID-19 and to establish their safety. A list of studies conducted worldwide is updated on the Danish Medicines Agency’s COVID-19 theme page.

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The European Medicines Agency (EMA): COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (1 April)

Danish Health Authority: Information to doctors on the potential prevention and treatment of SARS-CoV-2 and COVID-19 (in Danish only) (20 March)