FDA Issues Warning About Cubicin

The Food and Drug Administration has sent a warning to patients and doctors about the use of the intravenous antibiotic Cubicin. They have reported it can cause a life-threatening eosinophilic pneumonia. This is marked by accumulating a type of white blood cell, called eosinophils, in the lungs. Doctors and patients using this antibiotic should watch for symptoms which include difficulty breathing, shortness of breath, coughing, and fever.

The drug is sold by Cubist Pharmaceuticals. Cubicin is a brand name for a generic drug named daptomycin. It was approved for use in September, 2003. It was originally used to treat serious skin infections. In 2006 it started to be used to treat infections in the bloodstream. The following year the label was changed to indicate an increased risk for pulmonary eosinophilia.

The FDA has confirmed seven cases of eosinophilic pneumonia during the last six years along with 36 possible cases. The seven confirmed patients were each over the age of 60 years. Their symptoms occured within two weeks after the start of taking Cubicin therapy. All seven of the patients were being treated off-label for non-FDA approved conditions. The symptoms disappeared when the drug was stopped; however, it appeared once again, in two patients, when the treatment was restarted.