Safety updates on the risk of hepatotoxicity with oral ketoconazole

HSA, in consultation with its Medicines Advisory Committee, would like to update healthcare professionals on the outcome of its benefit-risk assessment of oral ketoconazole, following concerns raised internationally on liver toxicity associated with the drug. The assessment considered local signals, review of a cohort study on the risk of hepatotoxicity of anti-fungal drugs and alternative therapies. It was concluded that the benefit-risk profile of oral ketoconazole for treatment of fungal infections remains favourable for patients who have failed or are intolerant to other therapies if additional risk mitigation measures were taken, including weekly monitoring of serum alanine aminotransferase (ALT). Please refer to the letter for more details.

 
 
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.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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