Reactions 1382 - 17 Dec 2011

ADHD drugs not linked withserious CV events in adults

Current or new use of attention-deficit/hyperactivitydisorder (ADHD) medications is not associated with anincreased risk of serious cardiovascular (CV) events inyoung and middle-aged adults, suggest results of a USstudy published in JAMA.1 However, the researchers addthat a modestly elevated risk cannot be ruled out.

The retrospective, population-based cohort studyincluded data from 1986–2005 on 443 198 adults aged25–64 years, of whom 150 359 were receiving ADHDmedications at baseline, including methylphenidate(45%), amphetamine (44%), atomoxetine (8%) andpemoline (3%). During 806 182 person-years of follow-up, there were 1357 cases of myocardial infarction (MI),296 cases of sudden cardiac death and 575 cases ofstroke.

Multivariable logistic regression showed no increasedrisk of serious CV events with current or new use ofADHD medications, compared with non-use. Theadjusted rate ratio for current versus remote use was1.02 (95% CI 0.82, 1.28), with the upper limitcorresponding to an additional 0.19 events per1000 person-years for ages 25–44 years, and0.77 events per 1000 person-years for ages 45–64 years.

In an accompanying editorial, Dr Philip Shaw from theNational Human Genome Research Institute, Bethesda,says the JAMA study "is the most comprehensiveassessment to date of the cardiovascular safety ofADHD medications."2 He says that the study findingssupport the US FDA decision in 2006 not to add a blackbox warning to ADHD medications for adults andchildren regarding serious CV events. Dr Shaw adds thatthe study also provides no evidence to support routineECGs before starting ADHD treatment.

In response to this study, the US FDA has advisedpatients to continue to use their ADHD medication asprescribed.3 However, the agency maintains thatstimulant products and atomoxetine should generallynot be used by patients with serious heart problems, orby patients in whom an increase in BP or HR would beproblematic. Furthermore, the FDA recommendsperiodic monitoring for HR and BP changes in patientstreated with ADHD medications.1. Habel LA, et al. ADHD Medications and Risk of Serious Cardiovascular Events

in Young and Middle-aged Adults. JAMA: the Journal of the American MedicalAssociation : [11 pages], 12 Dec 2011. Available from: URL: http://dx.doi.org/10.1001/jama.2011.1830.

2. SHAW P. ADHD Medications and Cardiovascular Risk - Some HearteningNews. JAMA: the Journal of the American Medical Association : [2 pages], 12Dec 2011. Available from: URL: http://dx.doi.org/10.1001/jama.2011.1866.

3. FDA. Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review.Internet Document : 12 Dec 2011. Available from: URL: http://www.fda.gov.

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Reactions 17 Dec 2011 No. 13820114-9954/10/1382-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved