Rigors with Vancomycin

Conley, Nick

doi:10.7326/0003-4819-115-4-330_2

Ann Intern Med

1991

DOI: 10.7326/0003-4819-115-4-330_2

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Rigors with Vancomycin

Nick Conley¹

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Cited by 3 publications

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“…Infusion reactions were common initially, but technology led the innovator to a safer product (8). Differences in composition are well known (36) and even advertised (Baxter promotional material; Baxter, Bogota, Colombia), but DRA worldwide support commercialization of vancomycin generics based on scant in vitro data claiming unaltered efficacy (9).…”

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confidence: 99%

Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator

Vesga¹,

Agudelo²,

Salazar³

et al. 2010

Antimicrob Agents Chemother

101

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Generic versions of intravenous antibioticsare not required to demonstrate therapeutic equivalence with the innovator because therapeutic equivalence is assumed from pharmaceutical equivalence. To test such assumptions, we studied three generic versions of vancomycin in simultaneous experiments with the innovator and determined the concentration and potency of the active pharmaceutical ingredient by microbiological assay, single-dose pharmacokinetics in infected mice, antibacterial effect by broth microdilution and time-kill curves (TKC), and pharmacodynamics against two wild-type strains of Staphylococcus aureus by using the neutropenic mouse thigh infection model. The main outcome measure was the comparison of magnitudes and patterns of in vivo efficacy between generic products and the innovator. Except for one product exhibiting slightly greater concentration, vancomycin generics were undistinguishable from the innovator based on concentration and potency, protein binding, in vitro antibacterial effect determined by minimal inhibitory or bactericidal concentrations and TKC, and serum pharmacokinetics. Despite such similarities, all generic products failed in vivo to kill S. aureus, while the innovator displayed the expected bactericidal efficacy: maximum antibacterial effect (E max ) (95% confidence interval [CI]) was 2.04 (1.89 to 2.19), 2.59 (2.21 to 2.98), and 3.48 (2.92 to 4.04) versus 5.65 (5.52 to 5.78) log 10 CFU/g for three generics and the innovator product, respectively (P < 0.0001, any comparison). Nonlinear regression analysis suggests that generic versions of vancomycin contain inhibitory and stimulatory principles within their formulations that cause agonistic-antagonistic actions responsible for in vivo failure. In conclusion, pharmaceutical equivalence does not imply therapeutic equivalence for vancomycin.

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mentioning

confidence: 99%

Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator

Vesga¹,

Agudelo²,

Salazar³

et al. 2010

Antimicrob Agents Chemother

101

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Comparative safety of teicoplanin and vancomycin

Wilson

1998

International Journal of Antimicrobial Agents

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Life-Threatening Reaction to Vancomycin Given for Noninfectious Fever

et al. 1999

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Even with cautious slow infusion, intravenous vancomycin can precipitate life-threatening infusion-related reactions in some patients. Because of this, and to reduce selective pressure for vancomycin resistance, sources of fever that do not require treatment with vancomycin should be diligently investigated prior to the institution of empiric vancomycin therapy in febrile patients, particularly when the past medical history is suggestive of an alternative diagnosis.

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Rigors with Vancomycin

Cited by 3 publications

References 3 publications

Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator

Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator

Comparative safety of teicoplanin and vancomycin

Life-Threatening Reaction to Vancomycin Given for Noninfectious Fever

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