Losing Patience with Drug Labels Dismissing People with Obesity

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 dismissing people with obesity.

This happens because it is convenient to exclude people with obesity from clinical trials. This typically happens indirectly. Researchers want a tidy data set. But people with obesity bring diverse clinical problems with them. So even without explicitly excluding people with obesity from clinical trials, we can get screened out for any number of reasons.

So researchers and doctors learn how to safely use drugs in lean people. People with obesity? Not so much.

The Example of Posaconazole

In the symposium, one of the examples that surfaced was posaconazole. It’s a very useful drug for fungal infections that people can develop when they’re undergoing treatment for cancer. But it can also interact with cancer drugs, so doctors need to be careful about this possibility. They need to know how long the posaconazole hangs around in a person’s body after the last dose. They know this by looking at the drug’s label for something called half-life. For posaconazole, the drug label says it’s 27 hours in a person with normal liver function, 43 hours for patients with severe liver impairment. But it says nothing about obesity.

The fact is that for people with obesity, it takes much longer to wash this drug out of their bodies after the last dose – almost twice as long. This is important information, but there’s no mention of it in official prescribing information. None.

Do we need to mention that severe liver impairment is a rare problem compared to obesity?

“Be Patient”

There is a clear consensus that drugs can behave differently in persons with obesity. Drug trials and drug labels need to be considering, not dismissing, these important considerations for people with obesity. This information needs to be in drug labels.

Yet the response of FDA and industry is a bit of a yawn. At the symposium yesterday, Professor David Greenblatt of Tufts University asked pointedly:

“When will we see this happen? When is it going to happen that we get this data and it makes it into the label? It sounds like it’s not optional anymore.”

Dr. Gil Burckart of FDA responded:

“Be patient. I think it’s happening. We shared labels that show it’s happening slowly.”

Honestly, we have little patience for withholding information that helps with the safe use of drugs in people living with obesity. We have even less for dismissing their needs in drug trials and labels.

The information is here now. FDA and industry should act on it and share it without delay.

Click here for the ACCP position statement on this issue, here for a joint statement on the issue by major stakeholders in obesity care and advocacy. For more on posaconazole in persons with obesity, click here.

The Subway, painting by Jose Clemente Orozco / WikiArt

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September 9, 2024