In December 2009 the TGA was informed of the interim results of a clinical trial known as the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, conducted by Abbott Laboratories, which showed higher rates of cardiovascular events such as heart attack and stroke in patients using sibutramine than in those receiving a placebo.
In light of these data, the TGA has reinforced existing advice in the Reductil Product Information (PI), as well as adding a description of the SCOUT study and a precaution that the use of the drug should be ceased after an appropriate period of treatment if it has not been shown to be effective. While prescribing of the product has not been restricted and it has not been withdrawn from the market, the TGA's review of the safety of the product is ongoing, to determine if any further regulatory action is warranted.
A 'Dear Health Care Professional' letter was circulated by Abbott Australasia, the Australian sponsor of sibutramine, on 24 December 2009, advising doctors of the changes to the PI. This letter was sent in consultation with the TGA.
A copy of the current PI may be obtained from the TGA eBS Product and Consumer Medicine Information site.