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  • Clinical Implications
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Clinical Implication

Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs

The Pharmacogenomics Journal volume 4, pages 354–358 (2004)Cite this article

Variability in drug response to many therapeutic drug classes is well recognized. These interpatient differences have been seen for both drug efficacy and adverse effects. Pharmacogenomics (Pgx) aims to characterize the contribution of genetic polymorphisms to this variability in drug response and toxicity.1

One promise of Pgx is the application of genotype-guided therapy to maximize the likelihood of drug benefit, while minimizing the likelihood of harmful effects.2 As such, Pgx-based approaches to patient care might improve pharmacotherapy through more rational drug choices. These therapeutic decisions would be aimed at increasing the benefit–risk ratio of a given drug exposure, based on patient-specific genetic information.

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Acknowledgements

We thank Dr Steven Terra and Dr Julie Johnson for their thoughtful comments regarding the manuscript. While Dr Beasley is an employee of the US Food and Drug Administration, the views expressed in this paper do not reflect the official policy of the FDA. No official endorsement by the FDA is intended or should be inferred.

Author information

Authors and Affiliations

  1. Department of Pharmacy Practice, University of Florida College of Pharmacy, Gainesville, FL, USA

    I Zineh & A L Beitelshees

  2. University of Florida Center for Pharmacogenomics, Gainesville, FL, USA

    I Zineh & A L Beitelshees

  3. Department of Pharmacy Health Care Administration, University of Florida College of Pharmacy, Gainesville, FL, USA

    T Gerhard & A G Hartzema

  4. Department of Clinical Pharmacy, University of Colorado School of Pharmacy, Denver, CO, USA

    C L Aquilante

  5. US Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Rockville, MD, USA

    B N Beasley

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  1. I Zineh
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  3. C L Aquilante
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Correspondence to I Zineh.

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There are no conflicts of interest for any of the authors.

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Zineh, I., Gerhard, T., Aquilante, C. et al. Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J 4, 354–358 (2004). https://doi.org/10.1038/sj.tpj.6500284

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  • DOI: https://doi.org/10.1038/sj.tpj.6500284

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