Sibutramine Safety and Regulation in Singapore

There is a regulatory update regarding the use of sibutramine as a weight management drug for those who have a BMI of 30 or more. It can also be used in those with a BMI of 27 or more who also have a health-related issue around obesity. There has been a study called the SCOUT study that has looked at the effectiveness and safety of sibutramine in the management of obesity.

Sibutramine is licensed in Singapore for use in obesity as part of a weight management programme but its use has been suspended across the European Union, in part because of the SCOUT study. There are four different brands of sibutramine in use in Singapore, including Reductil, Ectiva, Reduxade and Slenfig.

In the SCOUT study, 10,000 overweight individuals were studied in a randomized, double blind, placebo-controlled study. Unfortunately, the study showed a 16 percent increase in heart diseases such as stroke and heart attacks when compared to placebo treated patients. The review committee for the European Union, the Committee for Medicinal Products for Human Use has felt that the risks far outweigh the benefits and have suspended its use in the EU. In other parts of the world, including Singapore, the drug continues to be used. Weight loss has been found to be modest with a loss of weight being a weight loss of 2 to 4 kg when compared to placebo. In the prescribing information on sibutramine, it is said that it shouldn’t be used in those with a known history of heart disease or stroke. The problem is that hidden disease is at a high likelihood in those who are obese and there may be some people who have heart disease and don’t know it. The drug was therefore suspended on January 21, 2010.

In the US, there was a small increase in risk of cardiovascular disease in those who took sibutramine as opposed to placebo. They didn’t suspend the marketing of sibutramine but instead issued a warning that it not be used in those who are at risk of heart disease or cerebrovascular disease.

In Singapore, all of the currently licensed drugs containing sibutramine have risk warnings attached to their labeling indicating a higher than average risk for those with coronary artery disease, cardiac tachycardia, congestive heart failure, arrhythmia, stroke or peripheral vascular disease. Even those with uncontrolled high blood pressure should not take sibutramine. There have been three adverse events reported. All patients recovered from their adverse event and are now not taking the drug.