Document Detail


The Safety Record of Fusidic Acid in Non-US Markets: A Focus on Skin Infections.
MedLine Citation:
PMID:  21546630     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Fusidic acid has been in clinical use outside the United States (US) since 1962 for skin infections, including methicillin-resistant Staphylococcus aureus (MRSA). Non-US labeling reflects safety concerns related to gastrointestinal, allergic, hematologic, and neurologic adverse events. We sought to survey available safety data on fusidic acid through the review of published global literature between 1962 and 2007 that contained data on oral fusidic acid safety and a centralized database (VigiBase) of spontaneous safety reports. Overall, the data were concordant with current product labeling, and no serious adverse events, such as death, hospitalization, or hepatotoxicity, were convincingly linked to fusidic acid monotherapy in skin infection patients. Other indications for fusidic acid use were also common, including osteomyelitis with similar reporting of labeled safety characteristics. Study quality was highly varied with limited structure to safety data collection methodology. Significant concerns for recall bias are present, yet these data remain informative in providing signals that require attention in the design and conduct of adequate and well-controlled clinical studies of fusidic acid for potential registration in the United States.
Authors:
Carl N Kraus; Barry W Burnstead
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  52 Suppl 7     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-06     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S527-37     Citation Subset:  IM    
Affiliation:
Infectious Diseases, Nanotherapeutics, Inc, Alachua, Florida.
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