Eosinophilic Pneumonia Can Occur During Daptomycin Therapy

Cheryl A. Thompson

BETHESDA, MD 29 July 2010—A rare, serious pneumonia can develop in patients receiving daptomycin, FDA announced today in a drug safety communication.

The agency said it made this determination after reviewing adverse-event reports and journal articles describing the occurrence of eosinophilic pneumonia in patients who were receiving daptomycin therapy.

Seven of those occurrences of eosinophilic pneumonia were "most likely associated" with daptomycin use, FDA said.

All seven of those patients received daptomycin to treat infections not listed in the Indications and Usage section of the antibacterial's labeling, the agency added. These patients were 60–87 years old. Four of them received the antibacterial to treat osteomyelitis.

FDA also identified 36 "possible" cases of eosinophilic pneumonia associated with daptomycin use.

According to the Merck Manuals online medical library, eosinophilic pneumonia does not involve infection of the pulmonary air sacs by bacteria, viruses, or fungi. Eosinophils fill the air sacs, and the patient may have a fever and cough, wheeze, and feel short of breath.

Since 2007, the labeling for daptomycin, marketed as Cubicin by Cubist Pharmaceuticals Inc., has listed pulmonary eosinophilia as one of the adverse reactions reported during postmarketing use.

The company, FDA said, will add new information about eosinophilic pneumonia to the product's labeling.

FDA approved daptomycin in 2003 for the treatment of certain types of complicated skin and skin structure infections. In 2006, the agency approved the drug for the treatment of Staphylococcus aureus bloodstream infections.