OW2024: A Blind Spot in Drug Labeling for Persons with Obesity

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 illness like cancer and its complications. The drug we’re talking about is an antifungal called posaconazole. People may need it when a fungal infection develops, as it sometimes does when a person is receiving intensive cancer treatment.

The research, presented by Caroline Apovian, Fatima Cody Stanford, and colleagues, shows that less than half of hematologists and oncologists know posaconazole will hang around in a person’s body much longer if that person has obesity.

Those same doctors all agree this is important information that belongs in posaconazole directions for use. In regulatory terminology, this is the drug labeling.

But it’s not there – leaving a blind spot for doctors.

A Prolonged Safety Risk

This blind spot creates a safety risk because posaconazole can interact with cancer drugs. Doctors know they need to wait after using posaconazole before resuming certain drugs at a full dose. But they don’t know they have to wait longer for a patient with obesity. Apovian et al explained the implications in their research abstract:

“Without the necessary label information, most practitioners are – and will continue to be – unaware of the prolonged safety risk when treating PwO with posaconazole and oncology drugs. The finding that oncologists will update their practice when informed demonstrates the importance of including this information in the posaconazole label. This case study is a practical example of the consequences when PwO are excluded from clinical trials.”

A Simple Fix

The fix is simple. Disclose the facts of an extended half-life in persons with obesity in drug labeling. Advocates from the Obesity Action Coalition, the Obesity Society, and other organizations have have called on FDA and Merck to make this simple change.

FDA gets it. Merck is dragging its feet. The posaconazole patent has expired and this drug is not a big money-maker anymore.

In the end, this is one case where doing the right thing is easy. We are hopeful, with some encouragement from FDA, that Merck will just do it.

Click here for the research abstract, here for a feature story from the Obesity Society, and here for new reporting on it from MedCentral. For further background, click here, here, and here.

The Blind, painting by Egon Schiele / WikiArt

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November 16, 2024