Evaluation of Adverse Drug Event Information in US Manufacturer Labels

Abstract

Pharmaceutical manufacturer labels are an important source of adverse drug event (ADE) information. The study objective was to determine the sufficiency of ADE reporting in US drug labels. A sample of 50 labels was evaluated from the top 200 drugs dispensed in the US. Electronic copies of labels were obtained and reviewed by 2 pharmacists for ADE incidence and discontinuation data. ADE incidence data were provided in 86% of labels. However, discontinuation rates due to ADEs and ADE incidence by dose were only reported in 60%. ADE incidence reporting by age (46%) or gender (18%) was also low. ADEs that occurred in less than 2% of the population were rarely reported. Incidence rates were based on small populations (median of 794) and short term studies (median of 84 days for chronic conditions). Labels for 19 drugs used chronically had no long term study data. Methods for collecting ADE data were stated in only 12% of labels. Adverse drug event and drug discontinuation data is under-reported in US labels. More information on adverse events causing discontinuation (especially serious events) and those related to dose, age, and gender is needed in labels to ensure safe prescribing and dispensing of drugs.

Side Effects from Use of One or More Psychiatric Medications in a Population-Based Sample of Children and Adolescents

“…This study is the first, to our knowledge, to specifically explore the association between the number of psychiatric medications used by children and adolescents, and the number and severity of side effects they experienced. This side effect study is also unique in evaluating subjects who have used medications for a long period of time, rather than the 2 to 3 month time period typical of randomized controlled trials from which side effect frequencies in pharmaceutical product labeling are derived (PDR 2013;Harrington et al 2011). Our approach has the advantage of characterizing ''real world'' use of medication, which is typically far longer than a few months, but has the disadvantage of missing data about any medications that caused side effects severe enough that the medications had to be discontinued prior to our query.…”

Existence of Notoriety Bias in FDA Adverse Event Reporting System Database and Its Impact on Signal Strength

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Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

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