Reductil, three other weight loss drugs suspended
The Health Sciences Authority (HSA) is suspending the sale of sibutramine products in Singapore with effect from today.
Sibutramine is marketed under four different brands in Singapore – Reductil®, Ectiva®, Reduxade® (all by Abbott) and Slenfig® (Apotheca Marketing). It was licensed for use in Singapore in 2001 as an adjunctive therapy to diet and exercise for obesity and for overweight patients.
The decision to suspend the sale of these products came about after HSA consulted its Pharmacovigilance Advisory Committee (PVAC) and a panel of external experts in metabolic diseases and cardiology about the risks and benefits of the drug.
From a benefit-risk assessment of the drug, HSA concluded that the increased cardiovascular risk of sibutramine outweighed the modest weight loss (up to 2.4 kg) seen in patients.
HSA’s decision also took into consideration the findings from the Sibutramine Cardiovascular Outcomes (SCOUT) study, the use of the product in Singapore, and developments in other international jurisdictions.
The SCOUT study was a large study designed to evaluate the cardiovascular safety after the long-term use of sibutramine in patients who had a history of heart disease and/or type 2 Diabetes Mellitus.
The study has shown a moderate increased risk of serious cardiovascular events associated with sibutramine use in patients with pre-existing heart disease.
It also demonstrated that the increased cardiovascular risk of sibutramine outweighed the modest efficacy seen.
Following the preliminary results of the SCOUT study in early 2010, HSA had updated healthcare professionals in January 2010 on the cardiovascular risks associated with the use of sibutramine and advised healthcare professionals not to prescribe the drug to patients with a history of heart disease.
In Singapore, all four sibutramine products are not allowed for use in patients with a history of cardiovascular problems such as coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia, stroke and inadequately controlled hypertension.
To date, HSA has received three non-serious cardiovasular-related adverse reaction reports that were associated with the use of sibutramine. All three patients had recovered following the discontinuation of the use of sibutramine products.
With the suspension of sales of sibutramine, doctors have been advised not to prescribe sibutramine to new patients.
Patients who have been prescribed sibutramine are advised to consult their doctors for a review of their therapy.
Patients should also consult their doctors if they experience cardiovascular-related side effects such as increased heart rate, irregular heartbeat, or any other discomforts after taking sibutramine.
Earlier this month, the US Food and Drug Administration (FDA) recommended against the continued use of sibutramine as the drug may pose unnecessary cardiovascular risks to patients.
Prior to that, the European Medicines Agency (EMA) had decided to suspend the marketing of sibutramine throughout Europe until additional data becomes available.
Abbott Laboratories (Singapore) Pte Ltd has set up a telephone hotline to handle any enquiries related to this suspension of sales at Tel: 6277 6310 from 9am to 5pm (Monday to Sunday).