Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: UMLS:C0028754 (obesity)
 124,988 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Obesity is a chronic disorder that is associated with significant co-morbidity and early mortality. Since the 1970s, amphetamines and amphetamine analogs have been trialed for weight loss. In 1997, the anorexigen agents, fenfluramine (Pondimin; AH Robins, Richmond, VA) and dexfenfluramine (Redux; Wyeth-Ayerst, Philadelphia, PA) gained worldwide attention when reports of associated cardiac valvulopathy and pulmonary hypertension emerged. A landmark report from the Mayo Clinic describing valvular heart disease (VHD) among women exposed to the anorexigen agent combination phentermine-fenfluramine ignited widespread concern, and the products were voluntarily withdrawn from the market by the manufacturers. Currently, the causal relationship between anorexigen agent use and valvulopathy has been validated, yet the extent and complexity of this important clinical issue remains ill-defined.
 ...
PMID:Anorexigen-induced cardiac valvulopathy and female gender. 1262 81

As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs.
 ...
PMID:The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen. 2477 87