Evolution of Pharmacological Obesity Treatments: Focus on Adverse Side‐Effect Profiles

ABSTRACT Pharmacotherapy directed toward reducing body weight may provide benefits for both curbing obesity and lowering the risk of obesity‐associated co‐morbidities. However, many weight loss medications have been withdrawn from the market due to serious adverse effects. Examples include pulmonary hypertension (aminorex), cardiovascular toxicity, e.g. flenfluramine‐induced valvopathy, stroke (phenylpropanolamine), excess non‐fatal cardiovascular events (sibutramine), and neuro‐psychiatric issues (rimonabant ‐ approved in Europe, but not in the US). This negative experience has helped mold the current drug development and approval process for new anti‐obesity drugs. However, differences between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in perceptions of risk‐benefit considerations for individual drugs have resulted in discrepancies in approval and/or withdrawal of weight‐reducing medications. Thus, two drugs recently approved by the FDA, i.e. lorcaserin and phentermine + topiramate extended release (ER), are not available in Europe. In contrast, naltrexone sustained release/bupropion sustained release received FDA approval and liraglutide 3.0 mg were recently approved in both the US and Europe. Regulatory strategies adopted by the FDA to manage the potential for uncommon but potentially serious post‐marketing toxicity include: (a) Risk Evaluation and Mitigation Strategy (REMS) programs, (b) stipulating post‐...
Source: Diabetes, Obesity and Metabolism - Category: Endocrinology Authors: Tags: REVIEW ARTICLE Source Type: research