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Published: December 2010

Withdrawal of sibutramine (Reductil) in New Zealand

Prescriber Update 31(4): 26
December 2010

The consent to distribute sibutramine containing medicines was formally revoked in New Zealand on 14 October 2010.

The withdrawal of sibutramine followed the Medicines Adverse Reactions Committee (MARC) recommendation on its benefits and risks. The review was prompted by the release of preliminary results of the Sibutramine Cardiovascular Outcome Trial (SCOUT). Subjects treated with sibutramine in this study had an increased risk of non-fatal myocardial infarction and non-fatal stroke compared to those given placebo.

Although the SCOUT study recruited high risk subjects, commonly with pre-existing cardiovasular disease, the MARC considered that the benefits of sibutramine on weight loss were modest. In addition the safety data for patients eligible for sibutramine was not sufficiently reassuring.

Of particular concern to the MARC and Medsafe was the difficulty in identifying patients at high risk for cardiovascular events, especially obese patients who are at very high risk and or may have had silent events.

Medsafe has advised patients to stop taking Reductil and to talk to a healthcare professional about alternative weight loss measures and maintenance programmes. There are no known adverse effects from stopping sibutramine abruptly.

Further information on the withdrawal of sibutramine in New Zealand is available at: www.medsafe.govt.nz/hot/media/2010/ SibutramineOct2010.asp

Sibutramine has also been withdrawn in Europe, the United States, Canada and Australia.

 

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