14 October 2010
A ministerial advisory committee has recommended that the consent to distribute the weight-loss drug sibutramine in New Zealand is revoked after its own review confirmed the risks outweigh the benefits of using the prescription medicine.
The Medicines Adverse Reactions Committee (MARC), a ministerial advisory committee which makes recommendations on appropriate action to be taken on medicine safety issues, concluded at its meeting this morning that the balance of risks and benefits of taking sibutramine was unfavourable.
"After an extensive review by MARC and Medsafe, we have concluded that the risks of using sibutramine outweigh any benefit from the very modest weight loss observed when using the medicine," Medsafe’s Principal Clinical Advisor Dr Enver Yousuf said.
"Healthcare professionals are advised not to issue any new prescriptions for sibutramine. Consumers taking sibutramine should see their doctor if they have any concerns and to seek advice on alternative methods of weight loss," he added.
Phamaceutical company Abbott has been informed of MARC’s recommendation and has decided to voluntarily withdraw sibutramine effective from today. Sibutramine, which is sold under the brand name Reductil in New Zealand, had also been recently withdrawn from sale in Australia, Canada and the United States.
Medsafe and MARC have been reviewing the benefits the risks and benefits of sibutramine after preliminary results of a major study of 10,000 patients found that sibutramine raises the risk of heart attacks and strokes.
Sale of sibutramine was suspended earlier this year by the European Medicines Agency.
Even before the preliminary results of the SCOUT (Sibutramine Cardiovascular OUTcomes) study were released, the New Zealand data sheet for sibutramine already contained precautionary information advising healthcare professionals against the use of sibutramine in patients with a history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia, or stroke.
It is recommended that patients taking Reductil make an appointment with their doctor at the earliest convenient time to discuss alternatives for losing weight. Doctors should not issue any new prescriptions for sibutramine. Pharmacists should stop dispensing sibutramine. Patients who wish to stop treatment before seeing their doctor can do so at any time. Patient and healthcare professional questions can be answered through the toll-free service number established by Abbott in New Zealand (0800 73 72 71) or by visiting
Pharmacy News
