Health Sciences Authority - Restrictions on the supply of tegaserod (Zelmac®) and special access for patients who have no therapeutic alternatives

Home > Health Products Regulation > Safety Information and Recalls > Product Safety Alerts > 2007 > Restrictions on the supply of tegaserod (Zelmac®) and special access for patients who have no therapeutic alternatives

05 Jul 2007: Restrictions on the supply of tegaserod (Zelmac®) and special access for patients who have no therapeutic alternatives

Upon the request of the Health Sciences Authority (HSA), Novartis (Singapore) has suspended further distribution of tegaserod in Singapore with effect from 3 April 2007. This measure was undertaken following the recent findings of a small increase in the number of cardiovascular ischaemic events in patients treated with tegaserod when compared to placebo and worldwide actions to suspend the sales of the drug in order to permit reassessment of the risk versus benefit of the drug (please see attached HSA Updates for more information)

While HSA continues to review data submitted by Novartis as well as monitor the regulatory developments in other jurisdictions, HSA has worked with Novartis on an interim arrangement to allow special access to tegaserod, under certain conditions, to a small group of patients who have been assessed by their doctors to have no other therapeutic options, and where the benefits of the drug may outweigh its risks.

Restriction on supply of tegaserod (Zelmac®)

In view of the new safety concern, the supply of tegaserod will currently be limited to gastroenterologists, internal medicine specialists and colorectal surgeons. Novartis will be required to obtain a written undertaking from doctors to whom the company supplies the product, that he (i.e. the doctor) will discuss the risks involved with his patients and obtain the patient's written consent before prescribing tegaserod.

HSA’s recommendations to healthcare professionals

Although the onus of deciding whether treatment with tegaserod is warranted in any particular patient lies with the prescribing doctor, in view of the recent safety information, HSA strongly recommends that tegaserod be prescribed only to patients where there are no therapeutic alternatives and where the risks-versus-benefits of the drug have been assessed to be favorable. HSA also recommends that doctors discuss the risks involved, as well as secure patient's understanding and consent prior to prescribing.

HSA recommends that patients prescribed tegaserod be monitored more closely for cardiovascular ischaemic events. Any serious adverse reactions suspected to be related to tegaserod should be reported to HSA's Pharmacovigilance Unit at Tel: 6866-3538 or faxed to 6478-6069.

Last updated on 02 Jul 2010 16:57:41