Posts Tagged ‘drug labeling’

Drug Labeling That Fails People with Obesity

August 31, 2023 — It is hard to believe. But a new commentary in Health Affairs Forefront tells us once again that drug labeling fails to assure safe and effective use for many important drugs by people with obesity. These are drugs for conditions other than obesity. But people with obesity may represent half or more of the people […]

Closing Out Summer with IFSO in Naples

August 30, 2023 — This comes as an early morning post of anticipation. Right now we are in a dark plane over the North Atlantic, anticipating two things. First we anticipate two intense days that will begin with a jolt as we land in a bright (and possibly wet) morning in Naples, Italy, for the IFSO meeting that started […]

A Troubling Gap: Body Size Diversity in Clinical Trials

July 7, 2023 — It’s a fact. People come in all shapes and sizes. FDA and pharmaceutical researchers know this. They know that body size and composition can have large effects on how a person responds to drugs. So why do we have such a troubling gap of body size diversity in clinical trials? In the AMA Journal of […]

Disruption, Discomfort, and Hazards in Obesity

June 3, 2023 — In case you missed it, the framework for obesity care is in the midst of great change. The availability of medicines that actually work to an extent never seen before is causing everyone to question presumptions that researchers and specialists have known to be false for some time. But these great changes are giving rise […]

Sunshine, Lollipops, Rainbows, and GLP-1 Meds

April 30, 2023 — Recent advances in medicines for treating obesity are stirring up quite a conversation. The enthusiasm for them is hard to miss. Subway ads, tabloid headlines, and celebrities are putting these meds front and center. From all this enthusiasm for the new GLP-1 medicines, the impression might be something like sunshine, lollipops, and rainbows. No doubt, […]

The Failure to Test Drugs in People with Obesity

March 29, 2023 — Scientists and regulators at the FDA have identified a critical gap in new drug development and labeling. It is the failure to test new drugs in people with obesity. Where there are differences in clinical responses and safety, labeling – the instructions for safe use – should reflect those differences. But in many cases, they […]