Clinical Studies Experience
Because clinical studies are conducted under varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The safety profile of ALTABAX was assessed in 2,115 adult and pediatric patients > 9 months who used at least one dose from a 5-day, twice a day regimen of retapamulin ointment. Control groups included 819 adult and pediatric patients who used at least one dose of the active control (oral cephalexin), 172 patients who used an active topical comparator (not available in the US), and 71 patients who used placebo.
Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of patients treated with retapamulin ointment, 6.6% (54/819) of patients receiving cephalexin, and 2.8% (2/71) of patients receiving placebo. The most common drug-related adverse events ( ≥ 1% of patients) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group.
The adverse events, regardless of attribution, reported in at least 1% of adults (18 years of age and older) who received ALTABAX or comparator are presented in Table 1.
Table 1: Adverse Events Reported by ≥ 1% of Adult Patients Treated With ALTABAX or Comparator in Phase 3 Clinical Studies
N = 1,527
N = 698
|Application site irritation||1.6||< 1.0|
|Creatinine phosphokinase increased||< 1.0||1.0|
The adverse events, regardless of attribution, reported in at least 1% of pediatric patients aged 9 months to 17 years who received ALTABAX are presented in Table 2.
Table 2: Adverse Events Reported by ≥ 1% in Pediatric Patients Aged 9 Months to 17 Years Treated With ALTABAX in Phase 3 Clinical Studies
N = 588
N = 121
N = 64
|Application site pruritus||1.9||0||0|
Other Adverse Events
Application site pain, erythema, and contact dermatitis were reported in less than 1% of patients in clinical studies.
In addition to reports in clinical trials, the following events have been identified during postmarketing use of ALTABAX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions
Application site burning.
Immune System Disorders
Hypersensitivity including angioedema.