Pediatric Advisory Committee Votes in Favor of Current Safety Monitoring for Most Drugs

Emma Hitt, PhD

June 22, 2010

June 22, 2010 ( UPDATED June 23, 2010 ) — The Pediatric Advisory Committee to the US Food and Drug Administration (FDA) met yesterday to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

The FDA reported in abbreviated presentations that they have observed no safety issues with anastrozole (Arimidex; AstraZeneca), bicalutamide (Casodex; AstraZeneca), or phentolamine mesylate (OraVerse; Novalar), and with the exception of 2 abstentions, the committee voted almost unanimously to concur with ongoing standard safety monitoring for these products.

Likewise, the FDA felt there were no new safety signals for the nocturnal enuresis agent desmopressin acetate and that the labeling covers adverse effects, including severe hyponatremia and seizures. The committee voted almost unanimously in agreement that standard ongoing safety monitoring for the product should be continued. One committee member, Carl D'Angio, MD, a neonatal pediatrician with the University of Rochester, New York, suggested that more data are required.

The FDA presented focused reviews on the rapid-acting insulins, insulin glulisine [rDNA] (Apidra; sanofi aventis) and insulin aspart [rDNA] (NovoLog; Novo Nordisk Inc), as well as the antihemophilic factor (recombinant) (Kogenate FS; Bayer), and stated that it sees no new safety signals and that routine monitoring for safety should continue for these agents.

The proton pump inhibitors (PPIs) lansoprazole (Prevacid; Takeda Pharmaceuticals North America, Inc), esomeprazole (Nexium; AstraZeneca), rabeprazole (AcipHex; Eisai Inc.), and omeprazole (Prilosec; AstraZeneca) were also discussed as a single class. Use of PPIs in pediatric patients is markedly increasing, but no new safety signals were identified, although some cases of fracture associated with underlying comorbidities were reported.

The committee voted in favor (with 1 abstention) that safety monitoring should continue on in a standard manner for PPIs, although the committee requested that an updated review of the safety of these agents be conducted within a year.

According to Dianne Murphy, MD, FAAP, director, Office of Pediatric Therapeutics, in the Office of the Commissioner, FDA, the committee expressed interest in knowing about the outcome from an upcoming FDA meeting on how to study these products in neonates and those younger than 1 year — an age group in which the increase in use has been remarkable.

The committee also heard a follow-up presentation on desflurane (Suprane; Baxter International Inc), which has been associated with rare cases of cardiac arrest and hepatitis in the pediatric setting. "Suprane is known to be very irritating to the airway, and in pediatrics particularly [it] can cause life-threatening laryngospasm and apnea," Dr. Murphy told Medscape Pediatrics.

The committee also voted unanimously that the label for desflurane does not adequately represent the risks and benefits for its intended use in the pediatric setting when the child is not intubated and is undergoing induction with an anesthetic agent. "The committee thought it appropriate to contraindicate this product for use in a nonintubated pediatric patient undergoing induction with an anesthetic agent," Dr. Murphy said.

For rocuronium bromide (Zemuron; Schering Corp), the committee voted unanimously that no changes should be made to the safety monitoring for this agent.

The next Pediatric Advisory Committee meeting will be held December 7, 2010.

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