Public-health advice during COVID-19 pandemic

EMA advises patients and healthcare professionals to only use chloroquine and hydroxychloroquine:

• for their authorised indications, including the treatment of malaria and certain autoimmune diseases;
• as part of clinical trials for the treatment or prophylaxis of COVID-19 or in national emergency use programmes in hospitalised patients under close supervision.

These medicines have not shown any beneficial effects in treating COVID-19 in the relevant treatment arms of ongoing large randomised clinical trials (e.g. the Solidarity trial, the Recovery trial and the Discovery trial).

Chloroquine and hydroxychloroquine may cause certain side effects, including heart rhythm problems. The risk of these side effects could be exacerbated when these medicines are taken at higher doses than those recommended for their authorised indications or in combination with other medicines that have similar effects on the heart, such as the antibiotic azithromycin.

These medicines may cause neuropsychiatric disorders, including agitation, insomnia, confusion, psychosis and suicidal ideation. They are also known to affect the liver, cause neuronal damage that can lead to seizures (fits), and lower blood sugar.

Patients should:

• only use chloroquine or hydroxychloroquine if they have been prescribed for them and a doctor is supervising their treatment;
• ask their doctor or pharmacist for any questions about the use of these medicines;
• report any suspected side effects to their national competent authority.

Healthcare professionals should:

• continue to use chloroquine and hydroxychloroquine in chronic conditions, prescribing only the usual supply of these medicines to patients in order to avoid unnecessary strain on supply chains;
• use these medicines for the treatment of COVID-19 as part of clinical trials preferably or in accordance with national established protocols in hospitalised patients under close supervision;
• carefully consider the possibility of side effects such as heart rhythm issues, particularly in patients with pre-existing heart problems, uncorrected potassium or magnesium imbalance, and 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;
• closely monitor patients with COVID-19 receiving chloroquine or hydroxychloroquine;
• report any suspected side effects to their national competent authority.

For more information, see:

• COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (29/05/2020)
• COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine(23/04/2020)
• COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes(01/04/2020)

EMA is aware of reports, particularly online, that some medicines could increase the risks of COVID-19. Research groups have been raising such hypotheses based on the current limited understanding of the biological mechanisms of the virus and comments or observations in individual patients.

EMA is continuously reviewing all available clinical evidence and is working with other regulatory and clinical bodies in providing reliable advice on the safe use of medicines during the COVID-19 pandemic. It will publish any new treatment recommendations as soon as available.

Advice is already available on:

• non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen;
• angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines).

At this stage, it is not possible to provide advice on the safety of many other medicines in patients with or at risk of COVID-19 infection.

This is because there are insufficient clinical or epidemiological data available and because understanding of the new virus and its interactions with the body’s natural defences is still incomplete. Observational data can be misleading, unless carefully collected and analysed.

When prescribing or administering medicines to COVID-19 patients, healthcare professionals should exercise their clinical judgement, taking into account:

• the medicine’s benefits and risks as described in its product information, including any warnings;
• any relevant guidance issued by EMA, WHO and the relevant national competent authorities;
• national treatment guidelines.

Patients already taking prescribed medicines should not interrupt their treatment, particularly if it is being used for the management of a chronic (long-term) condition. If patients have concerns, they should speak to their doctor or pharmacist.

Patients with suspected or confirmed COVID-19 should report any suspected side effects that they are experiencing with any medicine, including medicines taken to treat COVID-19 and pre-existing conditions.

Healthcare professionals treating COVID-19 patients should also report the suspected side effects that their patients are experiencing. 

These reports help regulators understand how medicines act in patients with COVID-19, complementing the knowledge generated in clinical trials and other studies.

They can report suspected side effects to:

• their national competent authority;
• the manufacturer of the medicine using the instructions in the package leaflet;
• their doctor, nurse or pharmacist (if reported by the patient).

Suspected side effects reports should be as clear and accurate as possible, including:

• information on the person who has experienced the side effect, including age and sex;
• whether the infection is confirmed through testing or is based on clinical symptoms;
• a description of the side effects;
• the name of the medicine (brand name as well as active substance) suspected to have caused the side effects;
• dose and duration of treatment with the medicine;
• batch number of the medicine (found on the packaging);
• any other medicines being taken around the same time (including non-prescription medicines, herbal remedies or contraceptives);
• any other health condition that the person who experienced the side effect may have.

Patients should speak to their doctor, nurse or pharmacist if they are worried about any side effect.

Suspected side effect reports of medicines authorised in the EU are publicly accessible via the www.adrreports.eu website.