Acute renal failure associated with use of inhaled tobramycin for treatment of chronic airway colonization with Pseudomonas aeruginosa

Acute kidney injury (AKI) is a common and serious problem affecting millions and causing death and disability for many. In 2012, Kidney Disease: Improving Global Outcomes completed the first ever, international, multidisciplinary, clinical practice guideline for AKI. The guideline is based on evidence review and appraisal, and covers AKI definition, risk assessment, evaluation, prevention, and treatment. In this review we summarize key aspects of the guideline including definition and staging of AKI, as well as evaluation and nondialytic management. Contrast-induced AKI and management of renal replacement therapy will be addressed in a separate review. Treatment recommendations are based on systematic reviews of relevant trials. Appraisal of the quality of the evidence and the strength of recommendations followed the Grading of Recommendations Assessment, Development and Evaluation approach. Limitations of the evidence are discussed and a detailed rationale for each recommendation is provided.

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“…However, significant nephrotoxicity with the use of inhaled tobramycin has been described in at least two cases [128,129]. …”

Section: Recommendations and Rationalementioning

confidence: 99%

Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1)

2013

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“…Indications such as bronchiectasis, ventilator-associated pneumonia, post-transplant airway infections and drug-resistant infections have also been suggested in the literature 4 10. Safety of inhaled tobramycin in off-label populations is also unknown, with specific concern of nephrotoxicity in patients with COPD 11 12. Further exploration of the effectiveness and safety is necessary in these off-label indications as their use can be anticipated to grow as use of inhaled tobramycin also continues to increase 13…”

Section: Discussionmentioning

confidence: 99%

Off-label use of inhaled tobramycin in Ontario, Canada

Tadrous

Khuu

Paterson³

et al. 2016

Thorax

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Inhaled tobramycin solution is indicated for use in the management of Pseudomonas aeruginosa in patients with cystic fibrosis (CF). Concerns have been raised regarding increasing off-label use of inhaled tobramycin, particularly for the management of COPD. We conducted an 8-year repeated cross-sectional study examining the indication for prescription claims for inhaled tobramycin in Ontario paid for by the Public Drug Benefit Program, which covers all Ontario residents with financial needs or aged 65 and older. Inhaled tobramycin prescription claims increased approximately 3 times greater from 86 prescriptions in the second quarter of 2007 to 261 prescriptions in the first quarter of 2015. Approximately half of all prescriptions (range: 46-65%) per quarter were dispensed to patients with CF. A large proportion of prescriptions (range: 31-36%) were dispensed to individuals who did not have a diagnosis of CF but had a diagnosis of COPD. In 2014, there were 324 unique users of inhaled tobramycin solution in the Ontario Public Drug Program (OPDP). Only half of users (54%; n=163) had a diagnosis of CF. Our study found increasing prescriptions of inhaled tobramycin from 2007 to 2015 in the OPDP with approximately half of these claims being for off-label use, mostly among patients with COPD.

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“…Patienten mit einem Kreatininspiegel >153 µmol/l (2 mg/dl) waren von Studien ausgeschlossen und es existieren mehrere Fallberichte über Hörverlust bzw. akutes Nierenversagen in Zusammenhang mit inhalativem Tobramycin [31,32].…”

Section: Nebenwirkungen Und Risiken Von Iabunclassified