Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

Autor: Greta Tarlos, Laszlo Jozsef Szentpeteri, Sándor Balogh, Reka Varnai, István Szabó, Attila Sik, Csilla Sipeky
Rok vydání: 2019
Předmět:
Zdroj: The Pharmacogenomics Journal
ISSN: 1473-1150
1470-269X
DOI: 10.1038/s41397-019-0123-z
Popis: Pharmacogenomic biomarker availability of Hungarian Summaries of Product Characteristics (SmPC) was assembled and compared with the information in US Food and Drug Administration (FDA) drug labels of the same active substance (July 2019). The level of action of these biomarkers was assessed from The Pharmacogenomics Knowledgebase database. From the identified 264 FDA approved drugs with pharmacogenomic biomarkers in drug label, 195 are available in Hungary. From them, 165 drugs include pharmacogenomic data disposing 222 biomarkers. Most of them are metabolizing enzymes (46%) and pharmacological targets (41%). The most frequent therapeutic area is oncology (37%), followed by infectious diseases (12%) and psychiatry (9%) (p CYP2D6, CYP2C19, estrogen and progesterone hormone receptor (ESR, PGS). Importantly, US labels present more specific pharmacogenomic subheadings, the level of action has a different prominence, and offer more applicable dose modifications than Hungarians (5% vs 3%). However, Hungarian SmPCs are at 9 oncology drugs stricter than FDA, testing is obligatory before treatment. Out of the biomarkers available in US drug labels, 62 are missing completely from Hungarian SmPCs (p
Databáze: OpenAIRE
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