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Effectiveness of FDA’s new over‐the‐counter acetaminophen warning label in improving consumer risk perception of liver damage
Author(s) -
Goyal R. K.,
Rajan S. S.,
Essien E. J.,
Sansgiry S. S.
Publication year - 2012
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.2012.01371.x
Subject(s) - acetaminophen , over the counter , drug labeling , off label use , consumer safety , medicine , pharmacology , business , risk analysis (engineering) , drug , medical prescription
Summary What is known and Objectives: 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 (v9.2) at a priori significance level of 0·05. Results and Discussion: 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. What is new and Conclusion: 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.