title: Effectiveness of FDA's new over-the-counter acetaminophen warning label in improving consumer risk perception of liver damage.
abstract: OBJECTIVE
  The Food and Drug Administration (FDA) issued new organ-specific warning label requirements for over-the-counter (OTC) analgesic products in order to make consumers aware of the risk of liver damage when using acetaminophen. However, awareness of a health risk alone cannot ensure consumers' engagement in safe and preventive behaviour. In this study, we attempted to: (i) measure consumer risk perception of liver damage due to the OTC acetaminophen products and (ii) analyse the effectiveness of the new organ-specific warning label in improving consumer risk perception of liver damage and intention to perform protective behaviours while using OTC acetaminophen products.
  
  
  METHODS
  This within-subject experimental study used a convenience sample of English-speaking adults visiting OTC segments of selected pharmacy stores in Houston. Participants were randomly exposed to the old and new warning labels and their respective risk perception (measured on a visual analogue scale, 0%, no risk, to 100%, extreme risk) and behavioural intention (measured on a 7-point Likert scale) were recorded using a validated, self-administered questionnaire. Descriptive statistics and non-parametric Wilcoxon signed-rank tests were performed using sas statistical software (v 9.2) at a priori significance level of 0.05.
  
  
  CONCLUSIONS
  Majority of participants (74.4%) were not aware of the new warnings; however, majority (67.8%) had prior knowledge of the risk. The mean risk perception score for the new warning label was found to be significantly higher (72.2% vs. 65.9%, P < 0.0001) than the old warning label. Similarly, the average intention score for the new warning label was significantly higher (5.06 vs. 4.86, P < 0.0001) than the old warning label.
  
  
  CONCLUSIONS
  The new warning label mandated by FDA is effective in improving consumer risk perception of potential liver damage and may encourage protective behaviour. However, future studies are essential to assess the impact of the new label on actual changes in consumer behaviour and subsequent reduction in acetaminophen-related morbidity and mortality.
authors.affiliation: Department of Clinical Sciences and Administration, College of Pharmacy, University of Houston, Houston, TX 77030, USA.
authors.forename: R K
authors.initials: RK
authors.lastname: Goyal
authors.forename: S S
authors.initials: SS
authors.lastname: Rajan
authors.forename: E J
authors.initials: EJ
authors.lastname: Essien
authors.forename: S S
authors.initials: SS
authors.lastname: Sansgiry
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology*; D054626:Consumer Health Information / Q000379:methods*; D004348:Drug Labeling; D005260:Female; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs / Q000009:adverse effects; D010465:Perception; D012306:Risk; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018712:Analgesics, Non-Narcotic; D004366:Nonprescription Drugs; D000082:Acetaminophen