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FDA panel discusses monitoring ADHD, other medications for children
Schelleman H. Pediatrics. 2011;127:1102-1110.
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Despite study results released online that suggest no increased risk for cardiovascular events in children taking medications for attention-deficit/ hyperactivity disorder, an advisory panel to the FDA recommended that the agency should continue to monitor at least one of these medications for adverse events.
Five years ago, the FDA mandated changes to the labels of all stimulant medications to carry a warning about the potential for cardiovascular events in young patients taking ADHD medications, but earlier this year, the agency announced study results that suggested these warnings may not be needed.
On Monday, the FDA Pediatric Advisory Committee recommended continued routine monitoring for pediatric patients who are prescribed guanfacine extended-release tablets (Intuniv, Shire), after noting 45 adverse events in pediatric patients who were prescribed Intuniv. Panel members said additional safety studies are expected in late 2012 and 2013, and these studies should provide some additional insights into these adverse events.
The advisory panel also unanimously agreed to recommend continued monitoring of pediatric patients who are prescribed escitalopram oxalate (Lexapro, Forest Laboratories) and valganciclovir hydrochloride (Valcyte, Genentech) and those patients who receive the Haemophilus influenzae type b conjugate vaccine Hiberix (GlaxoSmithKline), after a few scattered reports of adverse events after these medications’ use in children. They also recommended continued surveillance of topical calcineurin inhibitors. The panel discussed data that suggest that there have been no links to oncogenesis in the 5 years since these medications were first given black box warnings.
The FDA’s advisory panel met on the same day that study results were published in the journal Pediatrics, which indicated that children prescribed ADHD medications are no more likely to die of a severe cardiovascular event than those who do not take the medications.
Sean Hennessy, PharmD, PhD, of at the University of Pennsylvania, and colleagues reviewed patient data contained in Medicaid databases from five states and the HealthCore Integrated Research Database, which contains historical and current medical and pharmacy claims data from more than 44 million enrollees in Blue Cross and Blue Shield plans in 14 states.
The group identified 241,417 patients aged 3 to 17 years on ADHD medications and tracked their health records during the period they were on various ADHD medications, including amphetamines, atomoxetine or methylphenidate. The researchers then compared rates of sudden death, heart attack and stroke in patients taking ADHD medications with those not taking medications who were of the same age, sex and from the same state during a median of 609 days.
The researchers noted 28 deaths in the group exposed to ADHD medications (incidence: 1.79 per 10,000 person-years) and 607 in the control group (incidence: 3 per 10,000 person-years). Additionally, the researchers identified no cases of heart attack or stroke in the group that received ADHD medications and 11 cases in the unexposed group.
The researchers said, however, because the group of children and adolescents receiving ADHD medications had no validated reports of stroke and heart attack, they were unable to rule out relative increases in the rate of such events from use of the drugs.
Disclosure: Dr. Hennessy’s study was funded by Shire, a manufacturer of ADHD medications. The study's sponsor approved the protocol and had the right to provide non-binding written comments on a draft of the manuscript. The authors independently performed and analyzed the study and wrote the manuscript. The authors had the right to publish the results and to determine the paper's final wording. The Clinical and Translational Science Award 5KL2RR024132 provided funds for infrastructure. All authors received funding from Shire through their employers.
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