Like most novel treatments in medicine, it took an index patient for pediatric otolaryngologist Michael Rutter, MD, to realize the off-label potential of Ciprodex to treat granulation tissue in the airway.
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December 2019In this case, the patient was a young woman in the mid-2000s who was seriously injured after a drunk driver T-boned her car and ejected her through the windshield. She was intubated at the hospital, and metal stents were put in her airway. But the metal reacted with her trachea, and major granulation issues eventually sent her to Dr. Rutter, who is clinical director of the aerodigestive program at Cincinnati Children’s Hospital Medical Center in Ohio.
Dr. Rutter’s team removed the metal from her trachea “wire by wire” and reconstructed it. But every few days post-surgery, she would return “with basically life-threatening granulation in her airway,” Dr. Rutter said. “I’d clean it all out, I’d say I’ll see you in a week, and for about a month this happened. She actually looked like she was at risk of dying.”
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Then, the mother of invention kicked in. “More out of desperation than anything, I thought, ‘How do we stop the granulation tissue?’ I told her to start putting Ciprodex drops down her trach tube, and do it just like you would with an ear,” said Dr. Rutter. “We were doing three drops three times a day. And she came back a week later, and her trachea basically looked normal. And a few weeks later, we took her trach out. She’s gone on to get married, she’s had kids, she’s had a family, and literally, it saved her life.”
Welcome to the world of off-label use for otolaryngologists. In a field as relatively small as otolaryngology, figuring out treatment options, procedures, and equipment that can be used effectively isn’t just limited to the world of FDA approval. Examples include dripping Ciprodex into the airway; shooting Botox into salivary glands to reduce saliva production; injecting Avastin into the nose for patients with hemorrhagic telangiectasia; watering down budesonide as a rinse for chronic sinusitis; prescribing proton pump inhibitors for laryngeal reflux; and designing and hand-carving stents for laryngeal stenosis using silastic and other materials.
“If the only thing we did was stick to on-label, FDA-approved uses, there would be a great many patients whom we couldn’t treat, and there would be no advances in the field that led to additional on-label uses,” said Robert Sataloff, MD, DMA, professor and chairman of the department of otolaryngology–head and neck surgery at Drexel University College of Medicine in Philadelphia. “Practically everything that is on label started off as off label. People had to have a problem that needed a solution, and an idea of how to solve that problem, and then usually a pilot study, which sometimes was formal, but sometimes meant trying it and seeing how the patients did.”