Atarax™ (hydroxyzine) – New restrictions for hydroxyzine-containing medicines to further minimise the known risk of QT prolongation

GlaxoSmithKline (GSK) Pte Ltd would like to inform healthcare professionals that the European Medicines Agency (EMA) has recently strengthened warnings related to the safety of hydroxyzine-containing products to minimise the risk of QT prolongation. EMA’s review confirmed the previously known risk of QT prolongation and torsades de pointes and identified risk factors. As a result of this analysis and review, new restrictions have been introduced in the EU with the aim of reducing exposure to the medicine, particularly in the most vulnerable groups. Hydroxyzine should also be used at the lowest effective dose, for the shortest possible treatment duration. GSK will be updating the local package insert for Atarax™ to strengthen the warnings and impose further restrictions on the use of hydroxyzine. Please refer to the letter for more information.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.