Hospital Care

Growing Calls for Drug Labels to Include People with Obesity

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, Ed Silverman sums up the problem:

“Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.”

Incomplete Drug Labeling

Unfortunately, the gears grind slowly as pharmaceutical companies balk at taking the trouble to update their labels when they see no monetary upside. Take the example of posaconazole, an antifungal marketed by Merck and frequently used in patients receiving cancer care. Oncologists know that this drug interacts with chemotherapy agents. But most of them don’t know that it hangs around in a patient much longer if that patient has obesity. In recent research, oncologists told Caroline Apovian et al that they need this information to make good clinical decisions. Apovian explains:

“In obesity, since the half-life of posaconazole is prolonged, you have to wait longer before starting chemo agents. Why do you have a wash-out period? You have a wash-out period because posaconazole interferes with absorption and metabolism of chemo agents. You need a longer wash-out period for those with obesity. And this is not in the label.”

No Upside, No Action from Merck

Merck is spending big money to get a piece of the action in obesity treatment. But the company told Silverman they are unwilling to update their label to disclose this information. “It would not be appropriate to include information about a longer half-life people with obesity in the product labeling,” they argued.

Tufts Professor David Greenblatt, who has studied this problem, has a different view:

“Physicians caring for cancer patients need the information about prolonged half-life to support the best possible decisions about dosing of posaconazole together with anti-cancer drugs in these vulnerable patients. Including this information in the labeling is a logical and straightforward step.”

A Priority for FDA?

ConscienHealth founder Ted Kyle told Silverman, “I think the FDA wants to do the right thing, but the agency can be slow to act at times.” Peter Pitts, a former FDA associate commissioner, told Silverman this should be a priority for FDA because disclosure in drug labels about critical factors for safe use in people with obesity is the right thing to do:

“If we’re talking clinical trial equity, people with obesity are clearly an incredibly important part of the population. And obesity is a co-morbidity for almost anything. The bottom line is that mislabeling is misleading. And you shouldn’t just want to augment your label when you want another indication to boost sales.

“But the FDA doesn’t see bodies on the street, so it’s pushed down their list. Unfortunately, this won’t get done until the FDA makes it a priority.”

This is not a tough call. Where we have information that facilitates safe use of a drug in people with obesity, it should be in the drug label. It really is just that simple.

Click here for the new article from In Vivo. For further perspective, click here, here, and here.

Hospital Care, photograph from the Stop Weight Bias Image Gallery / Obesity Action Coalition

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February 4, 2025

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