Coronavirus: hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are subject to controlled distribution in Belgium to enhance monitoring of treatments

date: 01/04/2020

Hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are used to treat patients with COVID-19. The FAMHP has quarantined available stocks of these medicines to control their distribution, improve monitoring of their use and limit the risks to patients. Do not take any of these medicines without medical supervision.

Risks of adverse effects and drug interactions

Medication contain hydroxychloroquine and chloroquine may pose a cardiac risk. This risk can be increased if they are used in combination with certain medication, even long after treatment ends.

Kaletra (lopinavir & ritonavir) poses a risk of adverse effects on the liver, the heart and the respiratory system. It also interacts with other medication.

More details on these medicines are available in information leaflets and summaries of product characteristics for specialities marketed in Belgium, available via the FAMHP website.

Enhanced monitoring and follow-up by FAMHP

As for all medication, the adverse effects of hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are investigated and monitored by experts at the FAMHP, in collaboration with the other competent European authorities for medicines.

The FAMHP has recently quarantined available stocks of these medicines.

The controlled distribution of these medicines in Belgium means their use can be closely monitored and there can be better follow-up of potential adverse effects.

It is very important that healthcare professionals only use hydroxychloroquine and chloroquine for authorised indications or as part of clinical trials or emergency measures for treating COVID-19. Major clinical trials are underway to generate solid data to determine the efficacy and safety of chloroquine and hydroxychloroquine in the treatment of COVID-19.

Messages for patients: avoid self-medication

According to the Sciensano treatment guidelines, treatment of COVID-19 with hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) must be determined and initiated in hospitals. In some cases, treatment can be continued at home under medical supervision.

Do not take this medication without talking to your doctor first. Many counterfeit anti-COVID-19 medication are circulating on the internet. Do not buy any of these medicines or other products on illegal websites.

Messages for healthcare professionals

Hydroxychloroquine and chloroquine have a complex and variable pharmacokinetic profile and a relatively lengthy elimination half-life (up to 30 days). This must be taken into account particularly as regards the risk of drug interactions.

For more information on drug interactions with hydroxychloroquine and chloroquine, see the Flash VIG-news of 31.03.2020.

Adverse effects should be notified to the FAMHP

Patients and healthcare professionals are urged to report suspected adverse effects via www.notifieruneffetindé

Last updated on 06/04/2020