The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.
Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.
The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.
The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.
Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.