Xenical Short-Term Switch Odds Slimmer Than Long-Term – Experts
This article was originally published in The Tan Sheet
Executive Summary
Xenical's long-term prospect for switch appears promising, but its chances of being recommended for OTC sale by an upcoming advisory panel are slim, some switch experts say
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Obesity and CHD
Even without additional risk factors, obesity in young adulthood and middle-age carries an increased risk of hospitalization or death from coronary heart disease, cardiovascular disease or diabetes in older age compared to normal weight individuals, a study in the Jan. 11 Journal of the American Medical Association finds. For instance, the risk of death from CHD was 43% higher for obese individuals in the low-risk group compared to normal weight individuals at the same risk level, according to Lijing Yan, PhD, Feinberg School of Medicine, Northwestern University, et al. The findings, which were gleaned from a multivariable analysis of 17,643 participants in the Chicago Heart Association Detection Project, have "significant public health implications," the authors conclude. GlaxoSmithKline's switch application for the anti-obesity drug Xenical (orlistat) will be reviewed by two FDA advisory committees Jan. 23 (1"The Tan Sheet" Jan. 2, 2006, p. 3)...
Xenical Switch Proposal Will Face Advisory Committee Review In January
GlaxoSmithKline's Rx-to-OTC switch application for a 60 mg dose of orlistat (Xenical) will be reviewed during a joint meeting of FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees Jan. 23, according to the agency
Xenical Study Supports Proposed Nonprescription Dose, Glaxo Says
The "behavior modification" effect ofXenical adverse events could help allay concerns that OTC availability would lead to people using orlistat without making appropriate adjustments to their diets, according to the principal investigator of a study on the drug