Coronavirus: hydroxychloroquine: off-label use strongly discouraged and new benefit-risk assessment for clinical trials

date: 27/05/2020

The new COVID-19 treatment recommendations from Sciensano strongly advise against any off-label use of hydroxychloroquine outside of a clinical trial. Applicants for ongoing clinical trials must also update their benefit-risk assessment and demonstrate to the FAMHP that their risk reduction strategies during the trial are sufficiently adequate.

Since 7 April 2020, the advice to hospitals has been that the use of hydroxychloroquine should be mainly limited to clinical trials, although an exception could be made where no access to a clinical trial is possible. Following the publication of a retrospective analysis in the medical journal The Lancet on 22 May 2020, any off-label use of hydroxychloroquine outside of a clinical trial is now strongly discouraged in the new Sciensano recommendations.

In Belgium, all applicants for ongoing clinical trials using hydroxychloroquine must also update their benefit-risk assessment to take into account the conclusions of The Lancet study and must demonstrate that their risk reduction strategies are sufficiently adequate. Based on this, the FAMHP will decide whether the clinical trial can continue or if it should be suspended.

As a reminder, as no medicinal product is indicated for the treatment of COVID-19 in Belgium, doctors use medicinal products which were initially developed to treat other pathologies.

If you are using hydroxychloroquine (Plaquenil) for joint and/or skin disease or if you are taking hydroxychloroquine or chloroquine for any indication other than COVID-19, there is no reason to stop your treatment.     

Monitoring of adverse reactions

Since early March 2020, the FAMHP has been attentive to the use of COVID-19 treatments and, in particular, to their safety profile. In Belgium, we currently have 18 reports of adverse reactions for these treatments.
Regarding hydroxychloroquine, eight cases have been reported in the context of COVID-19. Unfortunately, one case turned out to be fatal in a patient on hydroxychloroquine and sarilumab. Of these eight cases, three relate to suspected cardiac adverse reactions.

These reports relate to suspected adverse reactions, for example medical events that have been observed after the use of a medicinal product, but are not necessarily related to or due to that medicinal product.

Regular updates to hospitals
Since 1 April 2020, a weekly report on the adverse reactions observed for these treatments in the European database has been put together and sent to pharmacovigilance contact points in Belgian hospitals.

The purpose of this report is to draw the attention of healthcare professionals to certain adverse reactions and to seek their collaboration to share, as quickly as possible, any adverse reaction suspected to have been caused by a COVID-19 treatment administered to patients in Belgium.

Report adverse reactions
Understanding of the new coronavirus is evolving rapidly, particularly with regard to possible interactions with medicinal products that patients may be taking in the treatment of COVID-19.

Information reported by patients and healthcare professionals, who can continue to report adverse reactions during the pandemic, is important and adds to the knowledge currently generated by clinical trials, scientific literature and the analysis of the European database. This allows recommendations to be made on the safe use of medicinal products as the pandemic evolves.

Last updated on 08/06/2020