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drug label

A collection of 23 issues

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

Concordance of Drug Labels and Clinical Annotations

Some drug labels have been identified by the FDA as containing pharmacogenetic biomarker information, but occasionally these variants are not listed in the Clinical Annotations on PharmGKB. The Clinical Annotations are based on literature available in peer reviewed journals and focus on germline variants. As a result, there are a

Annotated Health Canada product monographs now available on PharmGKB

PharmGKB now has annotated drug labels (referred to as product monographs) available from Health Canada/Santé Canada (HCSC). PDF copies of the product monographs were sourced from HCSC's Drug Product Database (DPD). As with the annotated U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and

Annotated PMDA drug labels now available on PharmGKB

PharmGKB now has annotated drug labels available from the Pharmaceutical and Medical Devices Agency (PMDA), Japan. The PMDA is a regulatory agency responsible for scientific reviews for the approval of drugs or medical devices, as well as safety monitoring after approval. The PMDA website provides PDF copies of package inserts

Clinical evidence support for biomarkers on FDA-approved drug labels

A recent article by Wang et al. in JAMA Internal Medicine reviews the clinical evidence support found on FDA-approved drug labels that are listed on the FDA's Table of Pharmacogenomic Biomarkers in Drug Labeling. The authors found that many labels on the list did not contain, or reference,

European approval of additional CFTR variants listed for ivacaftor use

The drug Ivacaftor (Kalydeco) was originally indicated for use in cystic fibrosis (CF) patients with one or two copies of the G551D variant (rs75527207) in the CFTR gene. The European Commission has approved the use of ivacaftor in patients with an expanded list of CFTR variants that all result in

Additional CFTR variants for ivacaftor treatment approved by FDA

The drug label for ivacaftor was recently amended and has been approved by the FDA. Ivacaftor was originally indicated only for use in Cystic Fibrosis patients with one or two copies of the G551D variant within the CFTR gene. In the amended ivacaftor drug label, the indication has been changed

PharmGKB Drug Labels: Description, Update and New Features

PharmGKB has recently added new information to drug label entries, standardized the annotations, and updated the website display. The overview page for drug labels contains high level information about each label at a glance, including: * Whether the drug label is currently on the FDA's Table of Pharmacogenomic Biomarkers

FDA-Approved Drug Labels, Pharmacogenomics and PharmGKB Evaluation

FDA-approved drug label standardization and pharmacogenomics People often use the wording "FDA drug labels" instead of "FDA-approved drug labels." To be clear, the FDA does not write drug labels; it is the responsibility of the drug company to provide them. The FDA reviews and approves labels,

FDA to post black box warning on codeine

The FDA has announced they will add a black box warning to the codeine drug label to contraindicate the use of the drug in children after tonsillectomy and/or adenoidectomy (see link). Codeine is a pro-drug that is converted to morphine, a reaction that occurs more efficiently in CYP2D6 ultra-rapid