| アブストラクト | Clinical trials can fail to detect rare adverse events (AEs). We assessed the ability of pharmacological target adverse-event (TAE) profiles to predict AEs on US Food and Drug Administration (FDA) drug labels at least 4 years after approval. TAE profiles were generated by aggregating AEs from the FDA adverse event reporting system (FAERS) reports and the FDA drug labels for drugs that hit a common target. A genetic algorithm (GA) was used to choose the adverse event (AE) case count (N), disproportionality score in FAERS (proportional reporting ratio (PRR)), and percent of comparator drug labels with an AE to maximize F-measure. With FAERS data alone, precision, recall, and specificity were 0.57, 0.78, and 0.61, respectively. After including FDA drug label data, precision, recall, and specificity improved to 0.67, 0.81, and 0.71, respectively. Eighteen of 23 (78%) postmarket label changes were identified correctly. TAE analysis shows promise as a method to predict AEs at the time of drug approval. |
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| ジャーナル名 | CPT: pharmacometrics & systems pharmacology |
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| Pubmed追加日 | 2018/10/26 |
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| 投稿者 | Schotland, Peter; Racz, Rebecca; Jackson, David; Levin, Robert; Strauss, David G; Burkhart, Keith |
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| 組織名 | Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office;of Translational Science, Center for Drug Evaluation and Research, Food and Drug;Administration, Silver Spring, Maryland, USA.;Molecular Health GmbH, Heidelberg, Germany.;Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research,;Food and Drug Administration, Silver Spring, Maryland, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30354029/ |
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