Cardiac, Neuropsychiatric Events With ADHD Drugs To Be Discussed By Pediatric Committee
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Pediatric Advisory Committee will address neuropsychiatric and cardiovascular events possibly related to attention deficit/hyperactivity disorder medications at a March 22 meeting
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FDA's Pediatric Advisory Committee will address neuropsychiatric and cardiovascular events possibly related to attention deficit/hyperactivity disorder medications at a March 22 meeting. "In continuation of a prior committee discussion of adverse events for the class of methylphenidate products used to treat attention deficit/hyperactivity disorder (ADHD), the committee will hear and discuss neuropsychiatric adverse events possibly related to other approved ADHD medications," FDA said. [Editor's note: To 1 watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] In June, the committee concluded that reports of suicidality with Johnson & Johnson's Concerta and other methylphenidate products did not constitute a new signal for concern (2 (Also see "J&J Concerta, Methylphenidate Adverse Events Not New Signal, Committee Says" - Pink Sheet, 30 Jun, 2005.)). In September, FDA issued a public health advisory on suicidal thinking in children and adolescents taking Lilly's Strattera for ADHD. The agency said it would not add a warning to other ADHD products pending an analysis of post-marketing adverse events from those products (3 (Also see "FDA Issues Strattera Public Health Advisory On Suicidal Thinking" - Pink Sheet, 29 Sep, 2005.)). "The committee will also receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications," FDA noted. FDA's Drug Safety & Risk Management Advisory Committee is meeting Feb. 9-10 to discuss studies that could be used to determine whether ADHD products increase the risk of cardiovascular events (4 (Also see "ADHD Drug Cardiac Events, COX-2s Are Topics For Drug Safety Committee Meeting" - Pink Sheet, 5 Jan, 2006.)). Shire's ADHD amphetamine product Adderall XR was suspended from the Canadian market in February 2005 due to reports of sudden death, cardiac deaths and stroke in pediatric and adult patients. The marketing authorization for the product was reinstated in August 2005 after it could not be conclusively determined that Adderall XR caused the events. In the U.S., Adderall XR carries a warning that sudden deaths have occurred in patients with structural cardiac abnormalities. The committee will hear pediatric adverse event reports for Adderall XR as part of its review under the Best Pharmaceuticals for Children Act. Adverse event reports for Abbott's Meridia (sibutramine), Bristol-Myers Squibb/Sanofi-Aventis' Avapro (irbesartan) and Genzyme's Clolar (clofarabine) will also receive review by the committee. On March 23, FDA's Psychopharmacologic Drugs Advisory will review Cephalon's ADHD drug Sparlon (modafinil), currently marketed as Provigil for narcolepsy. - Danielle Foullon |