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.

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

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.