Hsa Suspends Sales Of Sibutramine Products In S'pore

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HSA suspends sales of sibutramine products in S'pore

Posted: 11 October 2010 1810 hrs

SINGAPORE : The Health Sciences Authority (HSA) is suspending the sales of sibutramine products in Singapore with immediate effect.

It made the decision after consulting its Pharmacovigilance Advisory Committee (PVAC) and a panel of external experts in metabolic diseases and cardiology, HSA said in a statement on Monday.

The decision came after a benefit and risk assessment of sibutramine concluded that the increased cardiovascular risk of the product outweighed the modest weight loss seen in patients.

"The deliberations have taken into consideration the findings from the Sibutramine Cardiovascular Outcomes (SCOUT) study, the use of the product locally, and developments in other international jurisdictions," HSA said.

The SCOUT study was designed to evaluate the cardiovascular safety after the long-term use of sibutramine in patients who had a history of cardiovascular disease and/or Type 2 diabetes with at least one risk factor such as high blood pressure or high lipid levels.

About 10,000 patients, aged 55 years and above, who were overweight and obese were recruited in the study and treated up to six years.

The study has shown a moderate increased risk of serious cardiovascular events associated with sibutramine use in patients with pre-existing cardiovascular disease.

HSA said sibutramine is licensed for use in Singapore since 2001 as an adjunctive therapy to diet and exercise for obesity and for overweight patients with obesity-related risk factors such as Type 2 diabetes or disorders in lipid metabolism.

It is marketed under four different brands in Singapore - Reductil, Ectiva and Reduxade by Abbott, and Slenfig by Apotheca Marketing.

In Singapore, all four products are already not allowed for use in patients with a history of cardiovascular problems - such as coronary artery disease, congestive heart failure, stroke and inadequately controlled hypertension - since sibutramine was approved for use locally.

To date, HSA has received three non-serious adverse reaction reports - such as elevated blood pressure or palpitation - following the consumption of sibutramine products. All three patients had recovered after discontinuing the use of the products.

With the immediate suspension of sales of sibutramine products, doctors have been advised not to prescribe sibutramine to new patients.

HSA is also advising patients who have been prescribed sibutramine, or who experience side effects like increased heart rate, irregular heartbeat or other discomforts after taking sibutramine, to consult their doctors.

Sibutramine has also recently been withdrawn from sale in the US, Canada, Australia, New Zealand and the European Medicines Agency.

- CNA/al