The European Medicines Agency’s (EMA’s) safety committee has issued an alert on the risk of psychiatric disorders and suicidal behaviour with chloroquine or hydroxychloroquine.
The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the product information for all chloroquine or hydroxychloroquine-containing medicines following a review of available data that confirmed a link between the use of these medicines and the risk of psychiatric disorders and suicidal behaviour.
The review was initiated in May 2020 after the EMA had been informed by the Spanish Medicines Agency AEMPS of six cases of psychiatric disorders in patients with COVID-19 who were given higher than authorised doses of hydroxychloroquine.
It is already known that, even in approved doses for authorised indications, these drugs can cause a spectrum of psychiatric disorders. These side effects are listed in the product information of some chloroquine or hydroxychloroquine-containing medicines as rare side effects or side effects with unknown frequency.
The PRAC review confirmed that psychiatric disorders have occurred and may sometimes be serious, in patients with and without prior mental health problems. For hydroxychloroquine, the side effects may occur in the first month after treatment starts. For chloroquine, there was insufficient data to establish a clear timeframe.