If HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary want to bring radical transparency to U.S. healthcare, they can start by updating drug labels that lack good information for persons with larger bodies. A prime example is the antifungal drug posaconazole, marketed as Noxafil. Right now, it lacks a key piece of information to ensure safe and effective use in people with obesity.
Noxafil is prescribed routinely in cancer care to deal with deadly fungal infections during chemotherapy. Because of a drug-drug interaction, chemotherapy must be stopped during Noxafil treatment and shouldn’t be restarted until Noxafil has been washed out of the body. Scientists have known for years that obesity alters the metabolism of certain drugs, and scientists at Merck, the manufacturer of Noxafil, know that posaconazole is one of those drugs. Yet critical details about how long Noxafil remains active in the bodies of people with obesity remain absent from the Noxafil drug label. This oversight isn’t just a technical detail; it’s a stunning, fundamental omission. Studies show that Noxafil’s half-life is nearly twice as long in patients with obesity, which means physicians must delay the restarting of chemotherapy longer than in people without obesity. But if that washout period isn’t extended – if a physician doesn’t know to wait – they may restart chemotherapy too soon and put their patient at risk for serious adverse events.
The Noxafil label says nothing about this. No disclosure of half-life information for people with obesity. No washout extension. That’s not acceptable – especially when oncologists and hematologists, in a recent survey, overwhelmingly said they need this information to care for people with obesity and more than half of them did not know about it. Because it’s not in the label where it belongs.
The Noxafil label does include information of half-life for people with liver conditions, which affects less than 3% of the population, but not for the 40% of Americans with obesity. There’s no excuse for leaving it out because the peer-reviewed science is available.
We don’t need more studies to justify transparency – we only need action and accountability. Merck must update the label with pharmacokinetic data relevant to people with obesity. And if they won’t, the FDA must require it. Otherwise, physicians are forced to guess, and patients bear the risk.
Let’s stop sidelining 100 million Americans from safe, informed care. Bring radical transparency to labeling for drugs that work differently in persons with obesity. Posaconazle would be an easy place to start.
Caroline Apovian, MD, Co-Director, Brigham and Women’s Center for Weight Management and Wellness
Theodore K. Kyle, RPh, MBA, Founder, ConscienHealth
