EU: Weight Loss Pill too Risky

Friday Jan 22, 2010 (foodconsumer.org) -- The European Medicines Agency advised doctors to stop prescribing weight loss drug sibutramine, which is manufactured by Abbott Laboratories, Inc.  According to a Reuters report, the agency has concluded that the heart risk associated with the drug outweighs the benefits. 

Sibutramine, sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States, works as an appetite suppressant to help patients lose weight. 

The weight loss pill has been associated with a wide range of adverse effects, including increased risk of cardiovascular events, dry mouth, increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing or joint/muscle pain. 

The Food and Drug Administration issued a statement on Nov 21, 2009 advising healthcare professionals that the agency is reviewing preliminary data from a recent study that suggests that patients on the weight loss pill sibutramine were more likely to experience cardiovascular events including heart attack, stroke, resuscitated cardiac arrest or death than those who did not take the drug. 

The FDA approved this weight loss drug for the management of obesity in conjunction with a reduced calorie diet for obese people with a body mass index equal to or higher than 30 kg/m2.  People with a BMI equal to or greater than 27.2 kg/m2 were subscribed the drug, if they had other risk factors associated with obesity. 

The FDA said it had not made any conclusion yet, but suggested that the study “highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease or heart disease.

Reporting by David Liu and editing by Rachel Stockton