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Labeling Changes In Store For Hydroxychloroquine In EU After COVID-19 Experience

 
• By Vibha Sharma

The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.

Hydroxychloroquine
Chloroquine, Hydroxychloroquine Are Not Effective In Treating COVID-19 • Source: Shutterstock

The product information of all chloroquine and hydroxychloroquine-containing medicines marketed in the EU will have to be updated to warn about the risk of psychiatric disorders and suicidal behavior.

Changes to the product labeling of these medicines were recommended by the EMA’s pharmacovigilance committee, the PRAC late last...

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