title: Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?
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.
authors.affiliation: 1] Department of Clinical Research and Leadership, George Washington University SMHS, Washington, DC, USA [2] Department of Health Policy, George Washington University SMHS, Washington, DC, USA [3] Department of Integrative Systems Biology, George Washington University SMHS, Washington, DC, USA.
authors.forename: P W
authors.initials: PW
authors.lastname: Payne
mesh_terms: D000483:Alleles; D000927:Anticonvulsants / Q000009:adverse effects*; D044466:Asian People / Q000235:genetics*; D002220:Carbamazepine / Q000009:adverse effects*; D059910:HLA-B15 Antigen / Q000235:genetics*; D006801:Humans; D010597:Pharmacogenetics; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D000927:Anticonvulsants; C483536:HLA-B*15:02 antigen; D059910:HLA-B15 Antigen; D002220:Carbamazepine