Skip to main content

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

Abstract

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.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3

Notes

  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 http://www.who.int/mental_health/mhgap/evidence/depression/q2/en/index.html, 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 www.multum.com.

  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.

References

  • Bettman, J. R., Payne, J. W., & Staelin, R. (1986). Cognitive considerations in designing effective labels for presenting risk information. Journal of Public Policy and Marketing, 5, 1–28.

    Google Scholar 

  • Busch, S. H., Frank, R. G., Martin, A., & Barry, C. (2010). Characterizing declines in pediatric antidepressant use after new risk disclosures. Medical Care Research and Review (advance online publication, July 30, 2010).

  • Cawley, J., & Rizzo, J. A. (2008). Spillover effects of prescription drug withdrawals. Advances in Health Economics and Health Services Research, 19, 119–144.

    Article  Google Scholar 

  • Donald, S., & Lang, K. (2007). Inference with differences-in-differences and other panel data. Review of Economics and Statistics, 89, 221–233.

    Article  Google Scholar 

  • Fischer, M., Servi, A., Polinski, J., & Wang, P. (2007). Restrictions on antidepressant medications for children: a review of medicaid policy. Psychiatric Services, 58(1), 135–138.

    Article  Google Scholar 

  • Food and Drug Administration. (2003). FDA public health advisory. Food and Drug Administration. http://www.fda.gov/CDER/drug/advisory/mdd.htm.

  • Food and Drug Administration. (2004). FDA launches a multi-pronged strategy to strengthen safeguards for children treated with antidepressant medications. Press release October 15, 2004. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108363.htm.

  • Grijalva, C. G., Nuorti, J. P., & Griffin, M. R. (2009). Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. Journal of the American Medical Association, 302, 758harac.

    Article  Google Scholar 

  • Grossman, M. (1972). On the concept of health capital and the demand for health. Journal of Political Economy, 80, 223–255.

    Article  Google Scholar 

  • Guo, J. J., Curkendall, S., Jones, J. K., Fife, D., Goehring, E., & She, D. (2003). Impact of cisapride label changes on codispensing of contraindicated medications. Pharmacoepidemiology and Drug Safety, 12, 295–301.

    Article  Google Scholar 

  • Harris, E. C., & Barraclough, B. (1998). Excess mortality of mental disorder. The British Journal of Psychiatry, 173, 11–53.

    Article  Google Scholar 

  • Hirschfeld, R. M., Keller, M. B., Panico, S., Arons, B. S., Barlow, D., Davidoff, F., et al. (1997). The national depressive and manic-depressive association consensus statement on the undertreatment of depression. Journal of the American Medical Association, 277(4), 333–340.

    Article  Google Scholar 

  • Jick, H., Kaye, J. A., & Jick, S. S. (2004). Antidepressants and the risk of suicidal behaviors. Journal of the American Medical Association, 292, 338–343.

    Article  Google Scholar 

  • Linsenmayer, M., Scheffrahn, M., McLain, M. E., & Brenner, D. (1999). Frequency and demographics of depression: A study of the UT-Austin GSLIS student population. Austin, TX: University of Texas-Austin.

    Google Scholar 

  • Lleras-Muney, A., & Lichtenberg, F. R. (2003). The effect of education on medical technology adoption: Are the more educated more likely to use new drugs? National Bureau of Economic Research. http://www.nber.org/CRIW/papers/lleras.pdf.

  • Ludwig, J., & Marcotte, D. E. (2005). Anti-depressants, suicide, and drug regulation. Journal of Policy Analysis and Management, 24, 249–272.

    Article  Google Scholar 

  • Magat, W. A., Viscusi, W. K., & Huber, J. (1988). Consumer processing of hazard warning information. Journal of Risk and Uncertainty, 1, 201–232.

    Article  Google Scholar 

  • Mallick, R., Jieling, C., Entshuah, R., & Schatzberg, A. (2003). Depression-free days as a summary measure of the temporal pattern of response and remission in the treatment of major depression. Journal of Clinical Psychiatry, 64, 321–330.

    Article  Google Scholar 

  • McKeown, R., Cuffe, S., & Schulz, R. (2006). US suicide rates by age group, 1970–2002: An examination of recent trends. American Journal of Public Health, 96, 1744–1751.

    Google Scholar 

  • Olfson, M., Marcus, S. C., & Druss, B. (2008). Effects of food and drug administration warnings on antidepressant use in a national sample. Archives of General Psychiatry, 65, 94–101.

    Article  Google Scholar 

  • Olfson, M., Marcus, S. C., Druss, B., Elinson, L., Tanielian, T., & Pincus, H. A. (2002). National trends in the outpatient treatment of depression. Journal of the American Medical Association, 287, 203–209.

    Article  Google Scholar 

  • Olfson, M., Marcus, S. C., & Shaffer, D. (2006). Antidepressant drug therapy and suicide in severely depressed children and adults: A case-control study. Archives of General Psychiatry, 63, 865–872.

    Article  Google Scholar 

  • Pakenham, K. I., & Cox, S. (2008). Development of benefit finding in multiple sclerosis (MS) caregiving scale: a longitudinal study of relations between benefit finding and adjustment. British Journal of Health Psychology, 13, 583–602.

    Article  Google Scholar 

  • Parkinson, K., Price, J., Simon, K. I., & Tennyson, S. (2008). The influence of FDA advisory information and black box warnings on consumer use of prescription antidepressants (October 29, 2008). SSRN working paper #1292082.

  • Price, J., & Simon, K. I. (2009). Does the impact of medical research on medical practice differ by patient education? Journal of Health Economics, 28, 1166–1174.

    Article  Google Scholar 

  • Rappaport, N., Prince, J. B., & Bostic, J. Q. (2005). Lost in the black box: Juvenile depression, suicide, and the FDA’s black box. Journal of Pediatrics, 147, 719–720.

    Article  Google Scholar 

  • Ringold, S. (2005). Antidepressant warning focuses attention on unmet need for child psychiatrists. Journal of the American Medical Association, 293, 539–544.

    Article  Google Scholar 

  • Sharp, I. R., & Chapman, J. E. (2004). Antidepressants and increased suicidality: The media portrayal of controversy. The Scientifc Review of Mental Health Practice, 3.

  • Simon, K. I., Tennyson, S., & Hudman, J. (2009). Do state cost control policies reduce medicaid prescription drug spending? Risk Management and Insurance Review, 12(1), 37–64.

    Article  Google Scholar 

  • Smith, D. H., et al. (2006). The impact of prescribing safety alerts for elderly persons in an electronic medical record: An interrupted time series evaluation. Archives of Internal Medicine, 166, 1098–1104.

    Article  Google Scholar 

  • Soumerai, S. B. (2004). Benefits and risks of increasing restrictions on access to costly drugs in Medicaid. Health Affairs, 23(1), 135–146.

    Google Scholar 

  • Soumerai, S. B., Avorn, J., Gortmaker, S., & Hawley, S. (1987). Effect of government and commercial warnings on reducing prescription misuse: The case of propoxyphene. The American Journal of Public Health, 77, 1518–1523.

    Article  Google Scholar 

  • Stewart, D. W., & Martin, I. M. (1994). Intended and unintended consequences of warning messages: A review and synthesis of empirical research. Journal of Public Policy & Marketing, 13(Spring), 1–19.

    Google Scholar 

  • Thomas, C. P., Conrad, P., Casler, R., & Goodman, E. (2006). Trends in the use of psychotropic medications among adolescents, 1994 to 2001. Psychiatric Services, 57, 63–69.

    Article  Google Scholar 

  • Vernacchio, L., Kelly, J. P., Kaufman, D. W., & Mitchell, A. A. (2008). Cough and cold medication use by US children, 1999–2006: Results for the Slone survey. Pediatrics, 122(2), e323–e329. doi:10.1542/peds.2008-0498.

    Article  Google Scholar 

  • Viscusi, W. K. (1990). Do smokers underestimate risk? Journal of Political Economy, 98, 1253–1269.

    Article  Google Scholar 

  • Wagner, A. K., et al. (2006). FDA drug prescribing warnings: Is the black box half empty or half full? Pharmacoepidemiology and Drug Safety, 15, 369–386.

    Article  Google Scholar 

  • Weatherby, L. B., Norstrom, B. L., Fife, D., & Walker, A. M. (2002). The impact of wording in ‘Dear Doctor’ letters and in black box labels. Clinical Pharmacology and Therapeutics, 72, 735–742.

    Article  Google Scholar 

  • Wong, I. C. K., Besag Frank, M. C., Santosh, P. J., & Murray, M. L. (2004). Use of selective serotonin reuptake inhibitors in children and adolescents. Drug Safety, 27, 991–1000.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Sharon Tennyson.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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). https://doi.org/10.1007/s11150-012-9147-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11150-012-9147-8

Keywords

  • Warning labels
  • Prescription use
  • Antidepressants
  • FDA

JEL Classification

  • I11
  • I18
  • D83
  • M38