The Food and Drug Administration released warning on Thursday about the risk of life-threatening eosinophilic pneumonia with intravenous antibiotic Cubicin.

The FDA approved Cubist Pharmaceuticals Inc.’s Cubicin - brand name for the generic drug daptomycin - in September 2003 for treating serious skin infections and in 2006 to treat bloodstream infections.

The agent said seven confirmed cases of eosinophilic pneumonia between 2004 and 2010 are “most likely associated with Cubicin.” The FDA also found 36 possible cases of eosinophilic pneumonia, marked by accumulated eosinophils blood cells in the lungs of patients given Cubicin.

In the seven confirmed cases, the victims were all older than 60 involving off-label use of the antibiotic Cubicin for non-FDA approved conditions. The symptoms of eosinophilic pneumonia appeared within two to four weeks after starting Cubicin therapy. When the drug was discontinued, symptoms disappeared.
"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," according to a statement in a Drug Safety Communication.

The FDA recommended that daptomycin be stopped in patients showing any symptoms including fever, dyspnea, difficulty breathing, and new lung infiltrates seen with chest imaging.