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drug label

A collection of 22 issues

Updates to Drug Label Annotation Tags and Criteria for PGx levels

PharmGKB has made some changes in the Drug Label Annotation process to clarify the pharmacogenomic (PGx) relationships of biomarkers. PharmGKB curates all drug labels on the FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling and previously attempted to classify all labels with PharmGKB-created “PGx levels” . However many of the

CYP3A5 genotyping is a more accurate predictor of drug response than race alone

A new paper in Journal of Clinical Pharmacology from a group at Indiana University [PMID:37042314] implemented genotyping for CYP3A5 in a kidney transplant center. The team used CPIC guidelines for tacrolimus dosing based on CYP3A5 genotype. Implementation included provider education and clinical decision support in the electronic medical record.

Update to FDA-approved drug label annotations

In February 2020, we blogged about the FDA's newly released Table of Pharmacogenetic Associations. Since then, there has been much interest in understanding how that table was created, how it compares to the information on the drug labels, and how it compares to the FDA's Table

PharmGKB response to the FDA Table for Pharmacogenetic Associations

In February, the FDA posted the Table for Pharmacogenetic Associations (PGx Table), and PharmGKB and CPIC blogged about the table a few days later. We identified substantial areas of overlap and some differences between the gene-drug pairs listed on the FDA table and those with published CPIC guidelines. It is

Call for clarification on antidepressant pharmacogenomics

A new Perspective in Clinical Pharmacology and Therapeutics outlines the need for improved communication from pharmacogenomic testing companies and regulators on the role of pharmacogenomics in antidepressant therapy.Beginning antidepressant treatment can be an arduous experience for patients. Some patients fail to respond to first-line antidepressants, leading to an iterative

Annotated Swissmedic Drug labels now available on PharmGKB

PharmGKB now has annotated drug labels available from the Swiss Agency of Therapeutic Products (Swissmedic), a regulatory authority responsible for the authorization and supervision of therapeutic products in Switzerland. The Swissmedic drug label annotations are sourced through a collaboration with the Pharmaceutical Care Research Group (PCRG), Department of Pharmaceutical Sciences,

New and Updated PMDA label translations now available

New translations of package inserts from the Pharmaceutical and Medical Devices Agency (PMDA), Japan, as well as updated translations of existing package inserts, are now available on PharmGKB. The PMDA is a regulatory agency responsible for scientific reviews for the approval of drugs or medical devices, as well as safety

Introducing the new PharmGKB Cancer PGx Portal

PharmGKB has collected a number of resources for Cancer PGx into one easy location. There are tables with direct links to genes important for cancer drug response both for PD and PK, to cancer drug pathways, particular cancers that have PGx data, types of toxicities common to cancer drugs, and

FDA-approved drug label for abacavir updated

In an update to the FDA-approved drug label for abacavir (ZIAGEN), the wording within the Boxed Warning section has changed. It now uses stronger language to support screening for HLA-B*57:01 prior to treatment with abacavir. The following is an excerpt from the boxed warning: "All patients should

Cisplatin FDA label changes

In 2013 we blogged about the controversy with the FDA labeling for cisplatin and its warning for TPMT variants and increased risk of ototoxicity in children. The 2012 label stated: “Certain genetic variants in the thiopurine S-methyltransferase gene (e.g., TPMT*3B and TPMT*3C) are associated with an increased