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Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?

The Pharmacogenomics Journal volume 14, pages 473–480 (2014)Cite this article

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Abstract

In an effort to prevent potentially fatal adverse reactions to carbamazepine, the US Food and Drug Administration (FDA) issued an alert in 2007 containing pharmacogenomic information, which is still in effect today. The alert states that carbamazepine-induced skin reactions are significantly more common in patients with the human leukocyte antigen (HLA)-B*1502 allele and that these people are almost exclusively from ‘broad areas of Asia, including South Asian Indians.’ This study reviews the medical evidence relied upon by the FDA and finds that the alert does not accurately reflect the medical evidence relied upon in 2007 or evidence that has been generated over the last 5 years since the label was created. The FDA drug labeling should be modified to reflect current medical evidence.

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Acknowledgements

The author’s work was supported by research support from the National Heart Lung and Blood Institute, National Institutes of Health, grant no. K12 K12HL090020-01.

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Authors and Affiliations

  1. Department of Clinical Research and Leadership, George Washington University SMHS, Washington, DC, USA

    P W Payne

  2. Department of Health Policy, George Washington University SMHS, Washington, DC, USA

    P W Payne

  3. Department of Integrative Systems Biology, George Washington University SMHS, Washington, DC, USA

    P W Payne

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Correspondence to P W Payne.

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Payne, P. Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?. Pharmacogenomics J 14, 473–480 (2014). https://doi.org/10.1038/tpj.2014.14

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