Tobramycin adverse reactions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Adverse Reactions
TOBI® was generally well tolerated during two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received TOBI® in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks.
Voice alteration and tinnitus were the only adverse experiences reported by significantly more TOBI® -treated patients. Thirty-three patients (13%) treated with TOBI® complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
Eight patients from the TOBI® group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the TOBI® treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss. The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the TOBI® and placebo groups.
Nine (3%) patients in the TOBI® group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the TOBI® group, creatinine decreased at the next visit.
Table 1 lists the percent of patients with treatment-emergent adverse experiences (spontaneously reported and solicited) that occurred in >5% of TOBI® patients during the two Phase III studies.
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Adverse drug reactions (<5%) occurring more frequently with TOBI in the placebo-controlled studies and assessed as drug-related in ≥1% of patients:
Ear and labyrinth disorders
Tinnitus (3.1%, vs 0% for placebo)
Musculoskeletal and connective tissue disorders
Myalgia (4.7%, vs 2.7% for placebo)
Infections and infestations
Laryngitis (4.3%, vs 3.1% for placebo)
Adverse drug reactions derived from spontaneous reports
The following adverse reactions have been identified during postapproval use of TOBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ear and labyrinth disorders
Hearing loss (see WARNINGS – Ototoxicity)
Skin and subcutaneous tissue disorders
Hypersensitivity, pruritus, urticaria, rash
Nervous system disorders
Respiratory, thoracic, and mediastinal disorders
Bronchospasm (see WARNINGS – Bronchospasm), oropharyngeal pain[1]
References
Adapted from the FDA Package Insert.