(0333) Systematic Review of US Food and Drug Administration Labels: Evaluating Cough and Other Adverse Effects in Common Outpatient Medications

Introduction: The primary objective of this review is to describe, quantify and compare the prevalence of otolaryngological drug-related adverse effects by reviewing FDA labelling information for the most commonly prescribed outpatient medications. The secondary objective is to assess the limitations of FDA labeling information which are the basis for drug monographs commonly accessed by clinicians.

Methods: This study was a systematic review of FDA labeling information for the most prescribed medications per the United States Agency for Healthcare Research and Quality which fulfill the inclusion criteria of being an orally ingested medication and the exclusion criteria of a combination medication or a medication delivered intravenously, topically, intranasally, or via an inhaled route. Outcome measurements were absolute and relative incidence data of specific otolaryngological adverse effect and corresponding placebo rates. Data analysis involved descriptive statistics.

Results: 16% of the 300 most prescribed medications have an adverse effect (AE) of cough. Of medications with cough as an AE, the total mean AE rate of cough was 5%. 56% had an AE rate of 1-5% for cough and 28% had an AE rate of >5% with a mean AE rate of cough of 12.7% (range, 1-69; SD±15.8). 58% of medications with an AE of cough have placebo rates available for evaluation of relative incidence, with the mean reported difference between drug and placebo rate of +1.6%. Similar analysis was conducted for the other otolaryngological related adverse effects and presented in tables.

Conclusions: Awareness of otolaryngology related adverse effects and reported rates in FDA drug labeling information may help with a clinician’s evaluation of a bothersome sign, or a symptom reported by a patient. Our review is the first to-date to offer such a systematic evaluation in descriptive statistics on otolaryngological adverse effects of prescribed medications.