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The influence of FDA advisory information and black box warnings on individual use of prescription antidepressants


We examine how use of antidepressant medications is influenced by Food and Drug Administration (FDA) warnings about the increased risk of suicidality associated with pediatric antidepressant use. With individual-level data on antidepressant use from the Medical Expenditure Panel Survey, we consider whether consumer responses to FDA warnings differ among targeted (children) and non-targeted (adult) age-groups. Because the warning labels specifically mentioned new users, we examine separately the effects of the warnings on initiations of antidepressant therapy and on continued use of antidepressants. We find evidence consistent with reduced initiation of antidepressant use among the intended population of children, and that usage among children with more highly educated parents responded earlier to FDA information. However, we also find spillover effects of reduced initiation among the non-targeted population of adults. Overall, our results indicate that the FDA warning may have led consumers to perceive risks beyond those specifically mentioned.

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  1. Wong et al. (2004) point out that depressed individuals may not have enough energy to commit suicide, even if they have suicidal thoughts. However, those individuals’ first few weeks on antidepressants may give the individuals enough energy to act on their suicidal thoughts, before really helping their depression.

  2. These results were obtained by replicating the Lexis/Nexis search of major newspapers of Sharp and Chapman (2004). The number of positive (suicide goes down) and negative (suicide goes up) articles for 2000–2002 is as follows: 2000—6 positive, 9 negative; 2001—1 positive, 15 negative; 2002—3 positive, 4 negative. The small numbers are due to the fact that irrelevant articles containing the words “antidepressant” and “suicide” are excluded from the count.

  3. Stewart and Martin (1994) provide a comprehensive review of the literature on warnings.

  4. However, this could come either from greater ability to incorporate information or from greater ability to afford new medications.

  5. The World Health Organization provides treatment guidelines based on supporting evidence from medical research; the strength of the evidence for this guideline is sufficient for the World Health Organization to characterize this as a strong recommendation rather than simply a standard recommendation. Found online April 22, 2012 at, with supporting evidence provided.

  6. This sample design also accounts for the possibility that individuals very near the age cutoff of the warnings may feel that they too are at risk. In December 2006 the FDA extended the warnings to apply to individuals under age 25; our choice of age cutoffs for the sample means that our analysis will be unaffected by anticipation of this extension of the warning.

  7. Drugs are classified in MEPS using Multum class codes; see

  8. The warning labels may also lead some users of antidepressants to discontinue their use. For this reason, we explored the pattern of antidepressant quits or discontinuation in the sample of individuals who are observed to use antidepressants in the first year that they appear in the MEPS; however, this set of users is only a small fraction of the overall sample and we are unable to draw strong conclusions from the analysis.

  9. These estimates are available from the authors.

  10. These estimates are available from the authors.

  11. We examined the previous literature on trends in overall prescription drug usage by children and found many papers on specific drugs or diseases, but relatively few that cover the time period of our study and none that address overall prescription use for children during this time period. The most relevant papers showed increases in usage of medications for chronic illnesses in the 2002–2005 period (Pakenham and Cox 2008); declines in the usage of cold medications in the 1999–2006 time period (Vernacchio et al. 2008); and mixed results for changes in antibiotics use between 1996 and 2006 (Grijalva et al. 2009).

  12. However, the FDA warned of health risks associated with several anti-asthmatic inhalers in late 2005, and required stronger warning labels in June of 2006 “FDA calls for stronger warnings on asthma drugs”, Friday November 18, 2005 08:51 p.m. ET, Deena Beasley, Reuters news service. Antihistamine-related deaths among children under age two became widely publicized by early 2006.


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Correspondence to Sharon Tennyson.

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Parkinson, K., Price, J., Simon, K.I. et al. The influence of FDA advisory information and black box warnings on individual use of prescription antidepressants. Rev Econ Household 12, 771–790 (2014).

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  • Warning labels
  • Prescription use
  • Antidepressants
  • FDA

JEL Classification

  • I11
  • I18
  • D83
  • M38