Zelmac® tablet 6mg (tegaserod maleate) -Safety-related Package Insert Update [Novartis]

Novartis updates healthcare professionals on the restriction of use of Zelmac® (tegaserod maleate) for Irritable Bowel Syndrome (IBS) with Constipation and Chronic Idiopathic Constipation to women below the age of 55. The rationale for this restriction is that cardiovascular (CV) ischaemic events observed in the pooled clinical trial database were primarily seen in patients with prior history of CV ischaemic disease or in patients with CV risk factors as defined by the American Heart Association and American College of Cardiology. Novartis is thus restricting the use of Zelmac® to women below 55 years so as to reduce a key controllable risk factor for ischaemic cardiovascular disease.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

24 Feb 2021

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.