Posts Tagged ‘drug labeling’

FDA Faces Questions About Drug Safety for People with Obesity

May 24, 2024 — At a hearing this week fo the U.S. House Committee on Energy and Commerce, Representative Robin Kelly asked the Director of the FDA Center for Drug Evaluation and Research, Patrizia Cavazzoni, what the agency is doing to ensure that drug labeling adequately protects the safety of people with obesity: “Patients with obesity are frequently excluded […]

More Calls for People with Obesity in Drug Trials and Labels

January 26, 2024 — The calls are growing louder and more frequent to include people living with obesity in clinical trials and drug labels. Of course trials and labels for drugs that treat obesity include these patients. But the huge problem is that for everything else, more often than not, drug studies and labels exclude them. Now, the American […]

Fix the Blind Spot in Drug Trials Says Every Major Obesity Group

November 29, 2023 — It is time to translate words into action and fix the blind spot in drug trials and labeling for people with obesity. Every major obesity group in the U.S. issued this united call to action on Tuesday. This includes the ASMBS, Obesity Action Coalition, Obesity Medicine, Obesity Society, and STOP Obesity Alliance. It comes as […]

Do Cancer Drugs Work Safely for People with Obesity? Maybe

November 18, 2023 — At a time when nearly half of the U.S. population is living with obesity, this should be an easy question to answer. Obesity clearly causes some forms of cancer and as the prevalence of obesity is rising, patterns of cancer prevalence are shifting, too. So, yes, we should be able to say with great confidence […]

Drug Studies, Labels, and Dosing Only for Lean Persons?

November 8, 2023 — Public health experts have long been accounting for it. People are living in larger bodies. Better than 40% of U.S. adults have a body weight in the range of obesity. But new reporting from JoNel Aleccia for the Associated Press tells us that pharma and the FDA are not yet accounting for this fact. It’s […]

The Right Drug at the Wrong Dose in 4 Out of 10 Americans

October 23, 2023 — It’s a “deficit of information” we should correct, says FDA Commissioner Robert Califf. He is speaking about the gap in information about how to correctly dose drugs for people living with obesity. Karen Weintraub, reporting for USA Today, tells us this gap might mean that doctors are prescribing the right drug at the wrong dose […]

Reminder: Semaglutide Is Not DIY Weight Loss

September 29, 2023 — In case you haven’t been paying attention, FDA issued a new label warning for semaglutide that should remind everyone of a key fact – it’s not suitable for DIY weight loss. The warning went onto the label for the Ozempic brand of semaglutide. It is already there for the Wegovy brand and for the Mounjaro […]

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 […]