September 4, 2025 — Last week, in a meeting with senior staff from the FDA responsible for labeling, we were dumbfounded. We learned that these pharmacologists did not regard it as important for clinicians to know the half-life of posaconazole in persons with obesity. In fact, they told us “it could potentially be confusing.” On the spot this was […]
August 1, 2025 — A new physiologically based pharmacokinetic (PBPK) study demonstrates that the elimination half-life of posaconazole is significantly prolonged in individuals with obesity – especially those with a BMI ≥ 35 kg/m² – compared to people with normal weight. The labeled half-life for posaconazole is typically 26–35 hours. But in persons with obesity, this can extend to nearly 58 […]
July 3, 2025 — “If HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary want to bring radical transparency to U.S. healthcare, they can start by updating drug labels that lack good information for persons with larger bodies. ” In RealClearHealth yesterday, an editorial by Caroline Apovian and Ted Kyle called for policymakers at FDA to deliver […]
April 22, 2025 — Change is hard and people resist it. FDA is coming to terms with the idea of radical transparency and certainly drug labels are a good place to start. When we talk about drug labels for prescription drugs, it means the lengthy “prescribing information” that FDA reviews and approves. Its purpose is to tell doctors, pharmacists, […]
March 5, 2025 — FDA seems to be moving toward giving more and more attention to accurate drug labeling for people with obesity. Yesterday, Medscape published a deep exploration of this issue. The timing coincided nicely with Obesity Care Week and World Obesity Day, Responding to Medscape Medical News, FDA made reference to a workshop they sponsored on the […]
February 4, 2025 — Chasing the possibility of multi-billion dollar obesity medicines, pharmaceutical companies are jumping at the chance to spend billions in clinical research. But patient advocates find a reluctance from some of those same companies to take people with obesity into account in the drug labels for their products already on the market. Writing for In Vivo, […]
November 16, 2024 — Research presented at ObesityWeek 2024 shines a light on a blind spot in drug labeling for persons with obesity. No, we’re not talking about the latest buzzy drug for treating obesity. Rather, we are talking about a prime example of labeling for other drugs that people with obesity may need when they face a serious […]
October 29, 2024 — In some ways, it is nothing new. The medical needs of people living with obesity have been dismissed seemingly forever. But at the same time it is shocking to learn of Merck – a highly respected pharmaceutical firm – leaving doctors in the dark by choice about how one of their drugs acts differently in […]
September 9, 2024 — The American College of Clinical Pharmacology is meeting in Bethesda this week. On the opening day, ACCP convened a symposium to address critical questions about how drugs work in people with obesity. What can we – industry, FDA, and scientists – do better? Because all too often, drug labels to guide safe prescribing are effectively […]
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 […]
