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| |  Eosinophilic Pneumonia Associated With the Use of Daptomycin SILVER SPRING, Md -- July 29, 2010 -- The US Food and Drug Administration (FDA) is informing patients and health-care professionals about the potential for developing eosinophilic pneumonia during treatment with daptomycin (Cubicin), an intravenous antibacterial drug. Daptomycin was first approved in September 2003 to treat serious skin infections. In 2006, it was approved to treat bloodstream infections. Eosinophilic pneumonia is a rare, but serious condition in which eosinophils fill the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, difficulty breathing, and new infiltrates on chest-imaging studies. In 2007, pulmonary eosinophilia was added to the Adverse Reactions, Post-Marketing Experience section of the daptomycin product label. Since then, the FDA has reviewed published case reports of daptomycin-associated eosinophilic pneumonia,(1-4) and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System (AERS). That review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with daptomycin. Based on these reviews, the FDA determined that eosinophilic pneumonia can be associated with daptomycin use and requested that the manufacturer of daptomycin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label. The FDA recommends that physicians discuss the clinical benefits and potential risks of daptomycin with patients -- including the risk of eosinophilic pneumonia -- prior to beginning treatment. Additionally, the agency suggests that healthcare professionals closely monitor patients being treated with daptomycin for signs and symptoms of eosinophilic pneumonia. Daptomycin should be discontinued in those who exhibit such signs and symptoms, and they should be treated as clinically indicated. Adverse events involving daptomycin can be reported to the FDA MedWatch programme. References: SOURCE: US Food and Drug Administration
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