On March 22, 2013 the FDA approved TOBI Podhaler (tobramycin inhalation powder) for the treatment of Pseudomonas aeruginosa bacterial infections in cystic fibrosis patients. Compared to the original aqueous solution TOBI (tobramycin inhalation solution), the Podhaler system delivers the antibacterial medication tobramycin in a novel handheld, dry powder inhalation formula.
The safety and efficacy of TOBI Podhaler was demonstrated through a clinical trial of 95 adult and pediatric cystic fibrosis patients. All patients were also diagnosed with P. aeruginosa infection. Individuals received either placebo or TOBI Podhaler treatment for the initial four weeks of the study, after which all patients received treatment with TOBI Podhaler. Patients treated with TOBI Podhaler experienced a 12.5% increase in forced expiratory volume in one second (FEV1), while patients given placebo experienced only a 0.09% increase in FEV1.
The most commonly reported adverse effects were cough, hemoptysis (coughing up of blood), lung disorder, shortness of breath, fever, mouth and throat pain, dysphonia (changes in voice volume or quality), and headache.
TOBI (tobramycin inhalation solution) is an inhaled antibiotic medication indicated for cystic fibrosis patients whose lungs contain the bacteria Pseudomonas aeruginosa. Tobi was FDA approved on December 22, 1997 and is manufactured by Novartis. On March 22, 2013, the FDA approved a handheld, dry powder formulation called TOBI Podhaler.
FAERS data (from 11/01/1997 to 08/27/2012) was aggregated and standardized by the AdverseEvent RxFilter process. We identified 2,150 serious adverse events which listed TOBI as a suspect drug, while 1,352 of these reports listed TOBI as the primary suspect.
The most commonly reported side effects were death, upper respiratory tract infection, and infective pulmonary exacerbation of cystic fibrosis. We identified 467 hospitalizations and 304 patient deaths where TOBI was determined to be the primary suspect.