#USA #Atlanta #Obesity Action Coalition #FDA Drug Standards #Posaconazole

Patients with Obesity Demand Improved Drug Standards

Recent revelations at ObesityWeek 2025 underscored a pervasive concern among people with obesity regarding the lack of thorough testing and accurate labeling of medications intended for their use. According to a comprehensive study presented at this prestigious event, a staggering majority of individuals suffering from obesity expressed dissatisfaction with the current pharmaceutical practices pertaining to drug safety and efficacy.

The significance of this issue cannot be overstated; with over 40% of U.S. adults classified as having obesity, the demand for change is both urgent and necessary. Currently, many medications do not undergo essential pharmacokinetic testing in individuals with obesity before they receive FDA approval. As a direct consequence, healthcare providers often lack vital information regarding dosing, which is crucial for ensuring the safety and effectiveness of treatment for this substantial demographic.

The national survey revealed alarming insights:

• - 67% of participants were unaware of the lack of obesity testing for many drugs.
• - 88% were angered by this significant oversight.
• - 86% asserted that the FDA ought to mandate obesity-specific testing prior to drug approval.
• - An astounding 99% believed that drug manufacturers should promptly revise product labels to reflect altered responses in individuals with obesity.

Fatima Cody Stanford, MD, MPH, MPA, one of the study's authors, stated, “This is a clear and consistent message from the people most affected. Patients with obesity are demanding equal protection in drug safety and efficacy.”

Highlighting Critical Gaps in Current Practices

One alarming case highlighted in the study was the antifungal medication Posaconazole (Noxafil®), produced by Merck. Despite its approval without comprehensive testing in individuals with obesity, new pharmacokinetic data has shown that the drug's half-life is significantly prolonged in this population, an essential factor for determining correct dosing. However, Merck has yet to update the medication’s labeling to incorporate this vital information.

When presented with these facts during the survey, participants responded with heightened concern:

• - 74% reported that they were unaware of this crucial distinction in drug metabolism.
• - 73% strongly agreed that the medication's label should include this significant information.
• - A remarkable 73% expressed the opinion that the FDA should require Merck to rectify this issue promptly.

“This isn't a niche issue—it's a public health gap,” asserted Ted Kyle, RPh, MBA, co-author of the study. “With four in ten adults living with obesity, their physiological responses are too often excluded from research that informs clinical decisions. The public expects better accountability.”

Promoting Change and Advocacy through Research

The findings from this national survey were captured through online engagement in May 2025. The results were presented as a scientific poster at ObesityWeek 2025 in Atlanta, Georgia, which runs from November 4 to 7. The study's authors include a diverse group of professionals, such as Clara E. Tandar, BS, John C. Lin, BS, Gwyn Cready, MBA, James Zervios, BA, and others, who collectively emphasize the importance of accurate drug testing and labeling for individuals with obesity.

The Obesity Action Coalition (OAC), which sponsored the study, is a national nonprofit organization that advocates for the more than 85,000 individuals affected by obesity through educational initiatives and awareness campaigns. As this dialogue continues to evolve, the message is clear: patients with obesity are demanding equitable treatment in the realms of drug safety and efficacy, and the time for action is now.