The EMEA advisory committee has recommended that Abbott’s weight loss drug, sibutramine (Reductil), be withdrawn from the European market due to increased risk for cardiovascular side effects associated with the drug. Since sibutramine is only one of two obesity drug treatment available in Europe, sibutramine’s withdrawal will give orlistat a monopoly over the anti-obesity drug market until new weight loss drugs make their entrance.
Sibutramine (Reductil) as a Weight Loss Drug and Obesity Drug Treatment
Sibutramine is an appetite suppressant that has been available in the European Union since 1999. 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 or dyslipidaemia (abnormal levels of fat in the blood). Sibutramine is marketed under different brand names in different countries, including Reductil, Meridia, Ectiva, Sibutral, Reduxade and Zelium.
EMEA Recommends Sibutramine (Reductil) Withdrawal from Europe
On Thursday 21st January 2010, the advisory committee for the EMEA, the Committee for Medicinal Products for Human Use (CHMP), recommended suspension of marketing authorisation of weight loss drug, sibutramine, within Europe. The decision came following a safety review of data for the weight loss drug that indicate sibutramine is associated with increased health risks, namely serious cardiovascular events, such as stroke or heart attack. As a consequence, the agency’s advisory committee believes that the benefits of sibutramine no longer outweigh the product's risks.
This announcement was made on the same day that the US FDA announced that sibutramine be contraindicated for use in patients with a history of cardiovascular disease. Sibutramine is marketed as Meridia in the USA and Canada.
SCOUT Trial Results Lead to Sibutramine’s Withdrawal
Recommendation of sibutramine’s withdrawal from the European market is based on data from Sibutramine Cardiovascular OUTcomes (SCOUT) trial, which began in 2002 and enrolled nearly 10,000 patients. The SCOUT trial aimed to investigate the impact of long-term sibutramine treatment of cardiovascular endpoints in obese patients and overweight patients with known or high risk of cardiovascular disease.
The SCOUT trial was being undertaken as Abbott was trying to establish that sibutramine is safe in patients with a history of cardiovascular disease. However, outcomes for this trial have shown otherwise, and resulted in the EMEA advisory committee deeming that the benefits for sibutramine no longer outweigh the risks in any obese or overweight patients, whether they have a cardiovascular risk or not.
Abbot Complies with Withdrawal of Weight Loss Drug from Europe
Although sibutramine manufacturer, Abbott, believes that the risk:benefit profile for the weight loss drug is still positive when used appropriately in the indicated patient population i.e. those patients who are not at risk for cardiovascular disease, the company have agreed to withdraw the obesity treatment from all European countries.
Sibutramine Withdrawal Leaves Only One Obesity Drug Treatment Option
Currently, the obesity weight loss drug market is limited, with only two pharmacological obesity treatment options available in Europe – orlistat, which is available by prescription or at half the dose over the counter, and sibutramine. Consequently, sibutramine’s withdrawal will further limit options for doctors and patients, and allow orlistat to have a monopoly over this large patient pool.
Orlistat is a lipase inhibitor, which acts by stopping absorption of fat in the gastrointestinal tract, and is associated side effects, including flatulence and loose stools. Therefore, many patients may have tried and failed on orlistat already before trying sibutramine, or given up on this obesity drug treatment due to the unpleasant side effects. As such, it remains to be seen whether patients who were taking sibutramine make the switch to this only remaining obesity drug treatment available or stick to just diet alone and await new entrants to the anti-obesity market.
Sources:
Abbott Laboratories 2010, ‘Abbott to Suspend Marketing of Obesity Medicine Sibutramine in European Union Countries’, 21st January 2010
European Medicines Agency 2010, ‘European Medicines Agency Recommends Suspension of Marketing Authorisations for Sibutramine’, 21st January 2010
FDA 2010, ‘Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia’ 21st January 2010.
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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