IDSA News - May 2008
Vol. 18, No. 5  (Plain Text Version)

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In this issue:
•  FDA Lowers Vancomycin Breakpoints for Staph Infections
•  WHO Reports Progress on Dracunculiasis Eradication
•  IDSA Literature Review April 2008
•  From the President
•  Drug Approvals, Recalls, Adverse Events Update
•  Cefexime Available Again in the United States
•  Rift Valley Fever Outbreak in Madagascar
•  Vietnam Reports Vibrio cholerae Cases
•  Yellow Fever Reported in Liberia, Argentina
•  Brazil Has Large Dengue Fever Outbreak
•  Malaria Reported in Great Exuma, Bahamas
•  IDSA Urges FDA to Dedicate Resources to Antimicrobial Resistance
•  Polio Eradication Update: Cases Down Overall, But Type 3 Cases Up
•  IDSA Endorses Two Vaccine Financing Bills
•  Members on the Move
•  In the IDSA Journals
•  Welcome, New IDSA Members!

 

FDA Lowers Vancomycin Breakpoints for Staph Infections

The Food and Drug Administration (FDA) has lowered the breakpoints for vancomycin in the treatment of Staphylococcus aureus to reflect growing rates of resistance, and in response to urging from IDSA and others.

The Food and Drug Administration (FDA) has lowered the breakpoints for vancomycin in the treatment of Staphylococcus aureus to reflect growing rates of resistance, and in response to urging from IDSA and others.

According to a recently updated package insert for Baxter Healthcare Corporation’s vancomycin injection in GALAXY plastic containers, the susceptibility test interpretive criteria for S. aureus have been changed as follows:


Minimum Inhibitory Concentration (MIC) (mg/mL)


Susceptible (S)

Intermediate (I)

Resistant (R)

Updated

≤2

4-8

≥16

Previous

≤4

8-16

≥32

The breakpoints for other infections remain unchanged.

Clinicians are encouraged to make sure that clinical microbiology laboratories with which they are associated are using the revised vancomycin susceptibility breakpoints for S. aureus

(Note: see "High-Dose Vancomycin May Lead to Nephrotoxicity" in this month's IDSA Literature Review.)

The change follows mounting evidence that patients infected with S. aureus strains with MIC of 4 mg/mL were failing therapy.  Robert C. Moellering, Jr., MD, FIDSA, past president of IDSA, and Fred C. Tenover, PhD, FIDSA, published a “Viewpoints” article in the May 1, 2007 issue of Clinical Infectious Diseases detailing the rationale for lowering the breakpoints. The article was based on data Dr. Tenover had collected and presented to the Clinical and Laboratory Standards Institute (CLSI), which updated its breakpoints last year and submitted a “Citizens’ Petition” to FDA advising the agency to do the same.

For years, IDSA has been urging FDA to update breakpoints for key antimicrobials and backed legislation passed last fall requiring the agency to do so. This is the second time in recent months that FDA has updated breakpoints for a major antibiotic and suggests a new willingness on the part of the agency to modify these important benchmarks.

In related news, see the article in this issue of IDSA News on the recent FDA meeting to hear testimony on other key antimicrobial issues. [[LINK]]