Cubicin Side Effects May Increase Pneumonia Risk: FDA

Federal drug safety regulators are warning doctors and patients that the intravenous antibiotic Cubicin may increase the risk of pneumonia. 

On Thursday, the FDA issued a drug safety warning for Cubicin, indicating that a post-marketing review of the side effects of Cubicin indicate that it has been connected to at least seven cases of eosinophilic pneumonia since 2004.

Eosinophilic pneumonia is a rare condition where the lungs fill up with white blood cells. It causes fever, coughing, shortness of breath and difficulty breathing. The FDA recommends that any patient who has been or is being treated with Cubicin and develops these symptoms contact their health care provider immediately.

Cubicin (daptomycin) is an intravenous antibacterial drug that was first approved in 2003 for the treatment of serious skin infections. It was approved in 2006 for the treatment of bloodstream infections. It is manufactured and marketed in the United States by Cubist Pharmaceuticals.

In 2007, a label warning was added to the drug alerting patients and doctors that it could cause pulmonary eosinophilia, which is an inflammation of the lungs due to the increase in eosinophils, which is a type of white blood cell. However, the FDA says that since then the agency has reviewed published case reports and determined that the white blood cells can fill the lungs to the point of causing a type of pneumonia.

All seven reported cases dealt with patients between the ages of 60 to 87 years old. They all developed eosinophilic pneumonia two weeks to a month after being given Cubicin treatment. Their conditions were improved by taking them off of Cubicin and in five of the cases placing them on systemic corticosteroids. In two of the cases, eosinophilic pneumonia returned when they were placed back on Cubicin.