Sibutramine health risks raised by the SCOUT study prompted an FDA safety review of the weight loss drug. Results of the SCOUT trial indicate that treatment with Abbott’s Meridia increases cardiovascular side effects. The safety concerns have led to the FDA requesting a label upgrade for the obesity drug to include information about Meridia's heart risk, which may rule out the majority of sibutramine users from continuing treatment with Meridia.
Sibutramine (Meridia/Reductil) as an Obesity Drug Treatment
Sibutramine is an appetite suppressant that has been available in the USA since 1997. The weight loss drug is approved for the treatment of obesity and in overweight patients who also have other obesity related diseases, such as type-2 diabetes, controlled hypertension or dyslipidaemia. The weight loss drug is marketed in the USA and Canada under the brand name of Meridia. It is also known under various names in Europe, including Reductil, Ectiva, Sibutral, Reduxade and Zelium.
Sibutramine is a centrally acting drug, which has a dual mode of action. The obesity drug treatment acts at the 5HT receptors to reduce serotonin uptake, and also acts as a noradrenaline reuptake inhibitor. By doing so, sibutramine acts to reduce both food intake and moderate the drop in metabolism that is associated with weight loss.
Sibutramine (Meridia, Reductil) Side Effects
Sibutramine is a centrally acting drug, which means it enters the bloodstream and targets receptors in the central nervous system (CNS). As such, sibutramine causes common CNS side effects including dry mouth, anorexia, insomnia, constipation and headache.
Sibutramine side effects also include hypertension (an increase in blood pressure). Therefore, the FDA approved US label for the weight loss drug contains a warning regarding this, which is as follows:
“Meridia substantially increases blood pressure and/or pulse rate in some patients. Regular monitoring of blood pressure and pulse rate is required when prescribing Meridia.”
Sibutramine Cardiovascular OUTcomes (SCOUT) Trial Reveals Health Risks and Evokes Safety Concerns
Despite the sibutramine’s side effects, until recently, the obesity drug treatment was considered a rather safe weight loss drug. However, an ongoing safety study that aimed to determine the long-term effects of sibutramine on cardiovascular risk has revealed health concerns, and led to a safety review of the product by the US FDA.
The results of the SCOUT trial were revealed by the FDA in November 2009, when Abbott (manufacturer of sibutramine) informed the regulatory body of preliminary data for the trial. The SCOUT study results indicated that sibutramine treatment raised the heart risk in these patients, resulting in an increased risk for cardiovascular events, such as heart attack and stroke.
As a result of the safety review, on Thursday 21st January 2010, the FDA announced that the label for Meridia should be upgraded to include information based on the heart risk associated with this obesity drug. The statement issued by the FDA includes the following;
“The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label.”
The FDA request that Abbott upgrade Meridia’s label to include that the weight loss drug should not be used in patients with a history of cardiovascular disease, including:
- history of coronary artery disease (e.g., heart attack, angina)
- history of stroke or transient ischemic attack (TIA)
- history of heart arrhythmias
- history of congestive heart failure
- history of peripheral arterial disease
- uncontrolled hypertension
It is well known that cardiovascular disease is one of the leading causes of death in obese people. It is also a leading cause of death for diabetes, which is affecting obese people at epidemic proportions. Therefore, as a result of the FDA safety review regarding heart risks associated with sibutramine, the US restrictions for Meridia treatment will rule out most obese patients from using this drug, since many obese people are likely to be at risk for cardiovascular disease.
Readers may also be interested in the following articles:
Sibutramine Ban will Influence New Obesity Drugs
FDA 2009, ‘Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)', 20 November 2010
FDA 2010, ‘Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia', 21 January 2010
FDA 2010, ‘Meridia®(sibutramine hydrochloride monohydrate) Capsules, CS-IV’
Christine Redmond - My interest in science and healthcare has seen me working in the laboratory with tiny cells and DNA to helping set up a cancer clinical ...
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