Rate and Incidence of Adverse Reactions Associated With Ceftaroline Exposure: Importance of Cutaneous Manifestations.

BACKGROUND: Ceftaroline is a broad-spectrum, methicillin-resistant Staphylococcus aureus (MRSA)-active β-lactam approved for acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired pneumonia. Because of its favorable spectrum and pharmacokinetics, ceftaroline is frequently utilized for infections such as osteomyelitis and endocarditis. Ceftaroline has been associated with neutropenia, but evaluation of other adverse events remains limited.

OBJECTIVE: To describe the rates and types of ceftaroline-associated adverse events and determine if patients' baseline allergies affect the rates of an adverse event.

METHODS: A single-center, retrospective, observational analysis was conducted of all patients who received ceftaroline between November 4, 2011, and March 28, 2017, at the VA Saint Louis Health Care System. The Naranjo algorithm was utilized as a standardized method to evaluate likelihood that the adverse events were caused by ceftaroline therapy. Ceftaroline dose, duration, indication, and baseline allergy information were collected for all patients.

RESULTS: There were 75 patients who received 78 courses of ceftaroline identified for inclusion. The most common indications were osteomyelitis (51.3%) and ABSSSI (16.7%). Overall, 13/75 (17.3%) patients developed an adverse event, and 10/75 (13.3%) required discontinuation of ceftaroline. Rash was the most common adverse reaction and occurred in 7/75 (9.3%) patients, followed by neutropenia in 3/75 (4.0%) patients. There were no differences in baseline allergy characteristics between patients who experienced an adverse reaction to ceftaroline and those who did not.

CONCLUSIONS: When compared with clinical trials, ceftaroline use appears to be associated with an increased rate of overall adverse events, which is driven by cutaneous reactions.