First Databank, Inc, South San Francisco, CA, USA.
Ann Pharmacother. 2021 Oct;55(10):1185-1194. doi: 10.1177/1060028020983049. Epub 2020 Dec 31.
The US Food and Drug Administration (FDA) recommends using only FDA-reviewed pharmacogenetic information to make prescribing decisions based on genetic test results. Such information is available in drug labeling and in the Table of Pharmacogenetic Associations ("Associations table").
To compile a list of drug-gene pairs from drug labeling and the Associations table and categorize the pharmacogenetic information and clinical outcome associated with each drug-gene pair.
This was a cross-sectional analysis of pharmacogenetic information in the Associations table and individual drug labeling in March 2020. We used the Table of Pharmacogenomic Biomarkers in Drug Labeling to identify drug labels to review. We categorized the pharmacogenetic information for each drug-gene pair according to whether the purpose was to describe (1) polymorphisms affecting drug disposition (metabolism or transport), (2) polymorphisms affecting a direct drug target, (3) variants associated with adverse drug reaction (ADR) susceptibility, (4) variants associated with therapeutic failure, (5) a biomarker-defined indication, or (6) a biomarker-defined ADR. We also categorized the clinical outcome-efficacy, safety, or unknown-associated with each drug-gene pair. We reported counts and proportions of drug-gene pairs in each pharmacogenetic information and clinical outcome category.
We identified 308 drug-gene pairs, of which 36% were associated with a biomarker-defined drug indication, 33% with polymorphic drug metabolism, and 28% with ADR susceptibility. Most drug-gene pairs (n = 267, 87%) were associated with an efficacy or safety-related outcome.
FDA-reviewed pharmacogenetic information is available for more than 300 drug-gene pairs and can help guide prescribing decisions.
美国食品和药物管理局（FDA）建议仅根据遗传测试结果使用经 FDA 审查的药物遗传学信息来做出处方决策。此类信息可在药物标签和药物遗传关联性表（“关联性表”）中获取。
从药物标签和关联性表中整理出药物-基因对列表，并对与每个药物-基因对相关的药物遗传学信息和临床结果进行分类。
这是 2020 年 3 月对关联性表中的药物遗传学信息和个别药物标签进行的横断面分析。我们使用药物标签中的药物基因组生物标记物表来确定要审查的药物标签。我们根据药物遗传学信息的目的对每个药物-基因对进行分类，目的是描述（1）影响药物处置（代谢或转运）的多态性，（2）影响直接药物靶点的多态性，（3）与药物不良反应（ADR）易感性相关的变体，（4）与治疗失败相关的变体，（5）基于生物标志物的适应证，或（6）基于生物标志物的 ADR。我们还对与每个药物-基因对相关的临床结果（疗效、安全性或未知）进行了分类。我们报告了每个药物遗传学信息和临床结果类别中的药物-基因对数量和比例。
我们确定了 308 个药物-基因对，其中 36%与基于生物标志物的药物适应证相关，33%与多态性药物代谢相关，28%与 ADR 易感性相关。大多数药物-基因对（n=267，87%）与疗效或安全性相关的结果相关。
可获取超过 300 个经 FDA 审查的药物遗传学信息，可帮助指导处方决策。
