Obesity Care Week: Correct Drug Labeling for People with Obesity

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 subject in 2022 and said:

“The workshop helped the Agency highlight some of the scientific, regulatory, and practical challenges in evaluating the impact of obesity in adult and pediatric patients on safety, efficacy, drug dosing, and disposition. If a significant safety risk is identified pre-approval or post-approval, FDA can ask sponsors to generate additional data or conduct further analysis.”

Obesity care advocates from OAC, the Obesity Society, the STOP Obesity Alliance, and other organizations have been seeking this kind of commitment from FDA and industry for two years now.

Hearing FDA articulate a commitment to this principle is encouraging. Seeing the agency act to update a deficient label will be even more encouraging.

The Posaconazole Example

A case in point is posaconazole, an antifungal that people undergoing chemotherapy might need. This would include people with obesity. However, it is a drug that can interact with chemotherapy, so physicians might need to adjust or pause chemotherapy when a patient receives posaconazole. The idea is to give the posaconazole time to wash out of a patient’s system.

In a person with obesity, that takes longer. The elimination half-life – a measure of how long that clearance takes – is 80% longer in persons with obesity. But nowhere in the official prescribing information from Merck will you find that fact. Nowhere.

So far, Merck has been unwilling in discussions with obesity care advocates to update this information. We disagree with Merck and sincerely hope that FDA will encourage the company to make this disclosure in their drug labeling.

We are still waiting for Merck to do the right thing.

Click here and take a minute at the OAC Action Center to show your support for drug labels that meet the needs of people living with obesity. Click here for the new article on Medscape and here for more on the issue with posaconazole.

Drug Label, photograph by Michael Ermarth for FDA / Wikimedia Commons

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March 5, 2025