Food and Drug Administration's Obesity Drug Guidance Document A Short History

Division of Metabolism and Endocrinology Products, Office of Drug Evaluation II, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Circulation (Impact Factor: 14.43). 05/2012; 125(17):2156-64. DOI: 10.1161/CIRCULATIONAHA.111.028381
Source: PubMed
4 Reads
    • "The development of anti-obesity drugs represents a major research area and has been the focus of reputable pharmaceutical companies for many years. The drug regulatory agencies, the FDA in the US, and the European Medicines Agency (EMA) in Europe, considers a mean weight loss of at least 5% from baseline to be a valid primary efficacy point for approving a weight loss drug [88] [89] Rimonabant, a cannabinoid CB1 receptor antagonist, and sibutramine, a serotonin and noradrenaline reuptake inhibitor, initially showed promise when they were first launched. However, they were both withdrawn from the market because of the increased risk of depression and suicidal ideation in the case of rimonabant and cardiovascular disease with sibutramine in 2008 and 2010, respectively [90] [91]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Obesity is on the rise and the pursuit of efficient and safe treatment is ongoing. Available anti-obesity medical therapies have so far proved to be disappointing, whereas bariatric surgery is leading the way and offers long-term health benefits. Part of the success of bariatric surgery is thought to be mediated by gut hormones. A better understanding of the role of gut hormones within the gut-brain signaling pathway in the control of hunger, satiety, and energy homeostasis, has led to their therapeutic exploitation as possible anti-obesity drugs. In this review, we provide a summary of currently available treatment options for obesity from simple lifestyle modifications and bariatric surgery to traditional and novel medical therapies.
    Postgraduate Medicine 06/2015; 127(5):494-502. DOI:10.1080/00325481.2015.1048181 · 1.70 Impact Factor
  • Source
    • "In the sibutramine cardiovascular outcomes trial, subjects with pre-existing cardiovascular disease who were receiving long-term sibutramine treatment (5 years) had an increased risk of nonfatal MI and nonfatal stroke but not of cardiovascular death or death from any cause.5)13) On the basis of this trial, sibutramine was withdrawn from the EU in January 2010 and subsequently withdrawn from parts of Asia and the U.S. market in October 2010.14-16) However, sibutramine has still been found in adulterated non-prescription slimming products or natural herbal products.1)17) "
    [Show abstract] [Hide abstract]
    ABSTRACT: Sibutramine, which acts as an anti-obesity drug by inhibiting reuptake of serotonin and norepinephrine, has now been banned due to cardiovascular adverse effects. However, despite being banned, it is not uncommon for people to purchase products with sibutramine or its analogues used as adulterants in non-prescription slimming products or health foods available on the internet. Sibutramine has been associated with rare but serious adverse reactions such as cardiac arrhythmia including QT interval prolongation, myocardial infarction, and cardiomyopathy, as well as increases in blood pressure and pulse rate. Here, we report a case of a 32-year-old male who presented with dilated cardiomyopathy with massive left ventricular thrombus after taking unauthorized sibutramine-containing slimming pills sold over the internet.
    Korean Circulation Journal 09/2013; 43(9):632-5. DOI:10.4070/kcj.2013.43.9.632 · 0.75 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The prevalence of obesity has increased rapidly in the United States. Obesity affects about one third of the adult population and, even though it is attributed to excess calorie intake and inadequate physical activity, its etiopathogenesis is much more complex and is an area of active study. Lifestyle modifications (with a focus on increased activity and decreased calorie intake) have modest efficacy in the treatment of obesity. There is a dearth of safe and effective therapeutic modalities to treat obesity. In this review, we discuss the role of different treatment options in the management of obesity and its comorbidities, with a focus on recently approved drugs and the emerging role of bariatric surgery.
    CardioRenal Medicine 12/2012; 2(4):314-327. DOI:10.1159/000343803 · 1.76 Impact Factor
Show more