FDA Drug Safety Communication

FDA is informing patients and healthcare professionals about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug. Eosinophilic pneumonia is a rare, but serious condition where eosinophils fill the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing.

Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

Healthcare professionals should be aware that eosinophilic pneumonia has been reported in patients receiving Cubicin, discuss with patients the clinical benefits and potential risks of Cubicin, including the risk of eosinophilic pneumonia, prior to beginning treatment. Monitor patients being treated with Cubicin for new onset or worsening fever, dyspnea, difficulty breathing, and new infiltrates on chest imaging studies. In patients exhibiting signs and symptoms of eosinophilic pneumonia, discontinue Cubicin and consider treating as clinically indicated.

View the full FDA Drug Safety Communication on FDA.gov