Revised: 11 October 2010

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Withdrawal of Sibutramine (Reductil) in New Zealand

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 Sibutramine, which is sold under the brand name Reductil in New Zealand, had also been recently withdrawn from sale in Australia, Canada and the United States.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.

ENDS

Additional Information

• Sibutramine is used for the management of obesity including weight loss and maintenance of weight loss. Sibutramine works on the brain to help patients to feel full and consequently reduce their food intake.
• Reductil is currently the only brand of sibutramine approved for use in New Zealand.
• Medsafe and MARC have reviewed a large amount of data looking at the benefits and risks of sibutramine in patients who are eligible for treatment and patients who would not normally be treated with sibutramine.
• In response to the preliminary findings of the SCOUT study and pending the outcome of the MARC review, Medsafe reminded healthcare professionals to adhere to the precautionary advice contained in the sibutramine (Reductil) data sheet.

For media queries, please contact: Luz Baguioro, Media Advisor (04 496 2349, 021 802 622)

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Questions and Answers on sibutramine (Reductil)

What is sibutramine?

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).

Why has Abbott decided to withdraw Reductil (sibutramine)?

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.

What should patients do if they are currently taking Reductil?

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.

Why did Medsafe and the Medicines Adverse Reactions Committee review the benefits and risks of sibutramine treatment?

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.

What data have Medsafe and the Medicines Adverse Reactions Committee reviewed?

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.

What are the conclusions of Medsafe and the Medicines Adverse Reactions Committee?

Medsafe and the Medicines Adverse Reactions Committee concluded

• That there was an increased risk of serious cardiovascular events (such as heart attack or stroke) in patients with pre-existing cardiovascular disease.
• The data for patients eligible to take sibutramine was not conclusive.
• The benefits of sibutramine on weight loss were modest.

Medsafe and the Medicines Adverse Reactions Committee considered that

• Many obese patients are likely to have cardiovascular disease that has not yet been diagnosed by a doctor. These patients would be considered to be eligible to take sibutramine but would be at high risk of having a heart attack or stroke.
• That it would be difficult to identify these patients at high risk for cardiovascular events, who should avoid taking sibutramine.

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.