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Posts Tagged ‘Cubicin’

Pneumonia Associated with Patients using Cubicin: A Guideline for Health Care Professionals

by admin on: March 28th, 2011

Eosinophilic pneumonia is a rare, but serious medical condition that comprises a group of lung diseases. These lung diseases are characterized by the presence of eosinophils, a type of white blood cell, in the bloodstream and lungs of patients. This disorder is sometimes called pulmonary infiltrates with eosinophilia syndrome, and may result from the use of certain chemicals or drugs, an infection from parasites, or a fungal infection. The symptoms a patient presents with when they have contracted eosinophilic pneumonia include shortness of breath, difficulty breathing, cough, and fever. Health care professionals typically diagnosed this disorder using laboratory tests and X-rays.

Pulmonary eosinophilia was added (in 2007) to the ???Adverse Reactions, Post-Marketing Experience??? section on the product label for Cubicin. Cubicin was originally approved to treat skin infections in 2003, then approved to treat infections in the bloodstream in 2007. A recent evaluation conducted by the U.S. Food and Drug Administration (FDA) of the appearance of eosinophilic pneumonia and Cubicin (about 6???7 cases met criteria; 36 additional cases did not meet all criteria, but were supportive) identified the following traits that were deemed most-likely to be associated with Cubicin:

  • Fever
  • Concurrent exposure to Cubicin
  • Dyspnoea (difficult or labored breathing)
  • New infiltrates revealed by computer tomography scan or X-ray of the chest
  • Bronchoaveolar lavage demonstrating 25% or greater eosinophils
  • Patients demonstrate clinical improvement following Cubicin withdrawal

The FDA made the following recommendations regarding the future use of Cubicin to Healthcare professionals:

  • Be aware that some patients receiving Cubicin came down with eosinophilic pneumonia
  • Mention to patients where Cubicin is indicated that eosinophilic pneumonia is a potential risk
  • Closely monitor patients for symptoms and signs of eosinophilic pneumonia
  • If a patient begins expressing symptoms or signs of eosinophilic pneumonia, immediately discontinue Cubicin therapy
  • If a patient experiences an adverse event while using Cubicin, report this incident to the FDA???s MedWatch program