Europe – EU Regulatory Roundup: Neuropsychiatric disorders prompt safety probe of hydroxychloroquine

Cases of neuropsychiatric disorders in Spanish patients taking hydroxychloroquine for the treatment of COVID-19 have triggered a Europe-level review of the safety of the treatment.

Concerns about the risks posed by administering hydroxychloroquine to COVID-19 patients have so far primarily focused on the link between the drug and cardiac arrhythmia. However, the history of use of hydroxychloroquine in the treatment of conditions including lupus and malaria shows the drug is associated with other adverse events, some of which are now being seen in COVID-19 patients.

The Spanish Agency of Medicines and Medical Devices (AEMPS) has received reports of severe neuropsychiatric events including psychosis and suicidal ideation in patients taking the drug for the treatment of COVID-19.

In most cases, the neuropsychiatric disorders emerged shortly after the start of treatment with the drug, initially at an 800mg dose that was subsequently reduced to 400mg a day. Sanofi, which sells hydroxychloroquine as Plaquenil, has previously advised physicians to use the lowest dose possible in COVID-19 patients in light of reports of serious and life-threatening cases of QT prolongation.

AEMPS provided details of the neuropsychiatric adverse events linked to hydroxychloroquine to other regulatory agencies. The French National Agency for Medicines and Health Products Safety (ANSM) shared details of the AEMPS communication, adding that a Europe-level review is underway…