Prevalence and Therapeutic Classifications of FDA-Approved Prescription Drugs With Boxed Warnings
| Autor: | Christine M. Cheng, Joan Kapusnik-Uner, Colleen DeLizza |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
business.industry National library Public Health Environmental and Occupational Health Advertising Pharmacy Pharmacotherapy Family medicine Medicine Pharmacology (medical) Medical prescription business Pharmacology Toxicology and Pharmaceutics (miscellaneous) health care economics and organizations |
| Zdroj: | Therapeutic Innovation & Regulatory Science. 48:165-172 |
| ISSN: | 2168-4804 2168-4790 |
| DOI: | 10.1177/2168479013496091 |
| Popis: | To characterize and determine the prevalence of drugs with boxed warnings (BXWs) based on a review of structured product labels (SPLs) available on the National Library of Medicine (NLM) DailyMed website.A cross-sectional review was conducted of SPLs with BXWs for human prescription drugs on the NLM DailyMed website in July 2012. The presence of a BXW in the DailyMed version of the SPL was validated by cross-referencing a corresponding label on the FDA website. The SPLs were organized into drug groups, and descriptive statistics were used to determine the proportion of SPLs and drug groups associated with a validated BXW. The top therapeutic classes of drugs with BXWs were determined as well as the percentage of the top 100 BXW-associated drugs used in US hospitals and retail settings in 2012.Findings revealed that 35% (n = 4940/14,264) of drug labels on DailyMed and 35% (n = 650/1848) of the drug groups created were associated with a validated BXW. Central nervous system agents, antineoplastic agents, and cardiovascular drugs were the most common therapeutic classes. In 2012, 39% of the top 100 drugs were associated with a BXW. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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