EMA/PRAC reiterates psychiatric disorder risk for chloroquine and hydroxychloroquine

27 November 2020

The European Medicines Agency’s safety committee (PRAC) has recommended updating the product information for all chloroquine or hydroxychloroquine-containing medicines following a review of all available data that confirmed a link between the use of these medicines and the risk of psychiatric disorders and suicidal behavior.

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 authorized doses of hydroxychloroquine.

Chloroquine and hydroxychloroquine are approved in the European Union for the treatment of certain autoimmune diseases, such as rheumatoid arthritis and lupus, as well as for prophylaxis and treatment of malaria. They are not authorized for the treatment of COVID-19, but both medicines have been used as off-label treatment in patients with the disease. However, chloroquine and hydroxychloroquine have not shown any beneficial effects in treating COVID-19 in large randomized clinical trials.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK