TABLE 1.
Demographics and clinical characteristics of patients with a gentamicin ADR reported to the TGA (2016 to 2017) with an IgE-mediated allergy phenotypea
| Clinical characteristic (n = 17) | No. (%) of patientsb |
|---|---|
| Male patients | 9 (53) |
| Median age, yr (IQR) | 51 (38–66) |
| Another antibiotic implicated in causalityc | 8 (47) |
| Beta-lactam antibiotic implicatedd | 7 (42) |
| Othere | 2 (12) |
| No. of patients with gentamicin ADR after first dosef | 16 (94) |
| Median gentamicin dose (mg) pre-adverse event (IQR) | 300 (240–400) |
| i.v. gentamicin administration | 16 (100) |
| ADR onset within 5t1/2 of gentamicin dose | 15 (94) |
| Anaphylaxis | 6 (35) |
| Rash NOS/urticaria | 13 (76) |
| Angioedema | 9 (56) |
| Respiratory involvement | 5 (29) |
| Adrenaline administered (i.m., i.v., or inhaled) | 5 (29) |
| Intensive care admission | 3 (19) |
| Mortality (inpatient) | 0 (0) |
a
NOS, not otherwise specified; i.m., intramuscular; i.v., intravenous; ADR, adverse drug reaction; IQR, interquartile range; 5t1/2, five half-lives.
b
Except as noted otherwise in column 1.
c
Patients where another antibiotic was administered in the peri-ADR period in addition to gentamicin.
d
Amoxicillin or ampicillin (n = 4), flucloxacillin (n = 3).
e
Vancomycin (n = 1), clindamycin (n = 1).
f
One patient reported a reaction following the third dose.