Revised: 11 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 Sibutramine, which is sold under the brand name Reductil in New Zealand, had also been recently withdrawn from sale in Australia, Canada and the United States.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.
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Sibutramine is a medicine used in the management of obesity. It works on the brain to help patients to feel full and this helps patients to reduce their food intake.
Sibutramine is used along with diet and exercise in patients who are obese or overweight and also have other conditions such as type 2 diabetes.
Sibutramine belongs to the class of medicines known as serotonin noradrenaline reuptake inhibitors (SNRI).
The decision by Abbott to withdraw Reductil was made following actions taken in other countries. In addition the Medicines Adverse Reactions Committee has advised Medsafe that the risks of taking this medicine outweigh the benefits. The Committee have recommended that this medicine is withdrawn from use in New Zealand.
Patients should stop taking Reductil and talk to their doctor about alternative weight loss measures and maintenance programmes. There are no known adverse effects of stopping sibutramine.
Patients should return unused Reductil to their pharmacist.
Patients with any concerns should speak to their doctor or pharmacist.
Medsafe was made aware of concerns regarding the safety of sibutramine following notification of results from a clinical study (Sibutramine Cardiovascular Outcome Trial- SCOUT). The results from this study triggered a risk-benefit review in Europe that resulted in withdrawal of sibutramine containing medicines.
The Food and Drug Administration in the United States has also reviewed the benefits and risks of sibutramine and concluded they were unfavourable.
Medsafe and the Medicines Adverse Reactions Committee have reviewed the results of the SCOUT study. This trial studied the effects of sibutramine on patients with pre-existing cardiovascular disease. In New Zealand the product information (data sheet) states that sibutramine should not be given to patients with pre-existing cardiovascular disease.
Data from clinical trials which included patients who are eligible for treatment in New Zealand was also examined.
Medsafe and the Medicines Adverse Reactions Committee concluded
Medsafe and the Medicines Adverse Reactions Committee considered that
Minutes from the MARC meeting held on 23 September 2010 and the out-of-session meeting held on 11 October 2010 will be published on the Medsafe website shortly.