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Cardiovascular Safety of ADHD Medication Treatments

Published online by Cambridge University Press:  07 November 2014

Jeffrey H. Newcorn
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Extract

There are several important issues regarding the manner in which medications are tested prior to their release and monitored after approval that must be appreciated in considering issues related to cardiovascular safety of medication treatments for attention-deficit/hyperactivity disorder (ADHD) in adults. First, patients treated in clinical trials are not necessarily representative of those seen in practice settings, as specific inclusion/exclusion criteria in studies limit a variety of psychiatric, medical, and social factors that could potentially introduce confounds related to the collection and/or interpretation of efficacy, tolerability, and safety data. However, many of these factors are present in patients treated in clinical practice. In addition, the manner in which medications are administered in clinical trials does not necessarily replicate the way they are used in the community. Often, there are differences in titration schemes and dosing options. Also, in clinical trials, drugs are rarely studied in combination, although they are often used in this manner in practice settings. Further, Phase III clinical trials (at least in psychiatry) often do not enroll a large enough sample to evaluate infrequently occurring adverse events. Rather, the predominance of information regarding rare side effects is derived from voluntary reports made after a drug comes to market—and therefore likely under-reports the phenomenon. Finally, information regarding drug safety that comes to practitioners in the form of medication warnings or advisories may reflect concerns that extend beyond the strict interpretation of clinical trials data. These and other issues represent major obstacles in attempting to fully understand issues related to safety and tolerability of medication in “real world” settings.

Type
Expert Roundtable Supplement
Information
CNS Spectrums , Volume 13 , Issue S15: Best Practices in Adult ADHD: Special Considerations , October 2008 , pp. 5 - 8
Copyright
Copyright © Cambridge University Press 2008

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References

1.U.S. Food and Drug Administration. Pediatric Advisory Committee Report. www.fda.gov/ohrms/dockets/ac/oc06.htm. Accessed May 14, 2008.Google Scholar
2.U.S. Food and Drug Administration. Drug Safety and Risk Management Advisory Committee Report. www.fda.gov/ohrms/dockets/ac/cder06.html#DrugSafetyRiskMgmt. Accessed May 14, 2008.Google Scholar
5.Journal Watch. FDA Preliminary Report: Safety of Stimulant Medications. http://pediatrics.jwatch.org/cgi/content/full/2006/407/1. Accessed May 14, 2008.Google Scholar
3.Villalba, L. Safety Review: Sudden death with drugs used to treat ADHD. www.fda.gov/OHRMS/DOCKETS/AC/06/briefing/2006–4210b_07_01_safetyreview.pdf. Accessed May 15, 2008.Google Scholar
4.Wilens, TE, Prince, JB, Spencer, TJ, Biederman, J.Stimulants and sudden death: what is a physician to do? Pediatrics. 2006;118(3):1215–1219.CrossRefGoogle ScholarPubMed
6.Wren, C.Cardiac causes for syncope or sudden death in childhood. Arch Dis Child. 1999;81(4):289–291.CrossRefGoogle ScholarPubMed
7.Gutgesell, H, Atkins, D, Barst, R, et al. Cardiovascular monitoring of children and adolescents receiving psychotropic drugs: A statement for healthcare professionals from the Committee on Congenital Cardiac Defects, Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 1999;99(7):979–982.CrossRefGoogle Scholar
8.Biederman, J, Faraone, SV, Spencer, TJ, Mick, E, Monuteaux, MC, Aleardi, M.Functional impairments in adults with self-reports of diagnosed ADHD: A controlled study of 1001 adults in the community. J Clin Psychiatry. 2006;67(4):524–540.CrossRefGoogle ScholarPubMed
9.Kessler, RC, Adler, L, Ames, M, et al. The prevalence and effects of adult attention deficit/hyperactivity disorder on work performance in a nationally representative sample of workers. J Occup Environ Med. 2005;47(6):565–572.CrossRefGoogle Scholar
10.Vetter, VL, Elia, J, Erickson, C, et al. Cardiovascular monitoring of children and adolescents with heart disease receiving stimulant drugs: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee and the Council on Cardiovascular Nursing. Circulation. 2008;117(18):2407–2423.CrossRefGoogle Scholar
11.American Academy of Pediatrics/American Heart Association clarification of statement on cardiovascular evaluation and monitoring of children and adolescents with heart disease receiving medications for ADHD: May 16, 2008. J Dev Behav Pediatr. 2008;29(4):335.CrossRefGoogle Scholar
12.Faraone, SV, Biederman, J, Spencer, TJ, Aleardi, M.Comparing the efficacy of medications for ADHD using meta-analysis. MedGenMed. 2006;8(4):4Google ScholarPubMed
13.Harpin, VA.The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child. 2005;90(suppl 1):i2–i7.CrossRefGoogle ScholarPubMed