The drug sibutramine, found commonly in obesity drugs such as Reductil, Meridia and Zelium, among others, may increase a patients risk for cardiovascular events, according to data now under review by the European Medicines Agency.
Typically found in medications prescribed to obese and overweight patients who have additional risk factors such as dyslipidemia or type 2 diabetes, sibutramine abets patient weight-loss.
The drug is under scrutiny after the release of SCOUT trial (Sibutramine Cardiovascular OUTcomes) of 100,000 patients, which found that the risk of cardiovascular disease, stroke and heart attack increased in patients being treated with sibutramine-containing drugs.
Until review by the agency is completed, it is suggesting that those patients taking sibutramine-containing medicines use them with caution and those prescribed the drug be monitored for increased heart rates and blood pressure.
The agency advised that patients who do not see a loss of 5 percent of their body weight after three months of treatment cease taking the drug. In addition, sibutramine-containing drugs should not be prescribed to patients with coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia and cerebrovascular disease.
Sibutramine-containing drugs have been authorized for use since 1999 and are available under the following tradenames: Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Reductil, Reduxade, Sibutral, Sibutril, Siluton, Sitrane, Zelium and Zelixa.
Currently, the agency’s Committee for Medicinal Products for Human Use is gauging the ramifications of the SCOUT findings and will review the risks of the drug at its meeting this month.