Lotensin, Xenical, Brevibloc Need Continued Pediatric AE Monitoring – Committee
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Pediatric Advisory Committee recommends continued monitoring for an additional year of pediatric adverse events associated with Novartis' anti-hypertensive Lotensin
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FDA's Pediatric Advisory Committee recommends continued monitoring for an additional year of pediatric adverse events associated with Novartis' anti-hypertensive Lotensin . The committee decided to require further monitoring of Benazepril, marketed as Lotensin, Lotensin HCT and Lotrel , for two reasons: 1) the lack of data regarding the number of children administered the drug during the one-year monitoring period that followed a pediatric exclusivity award; 2) the current adverse event reporting system's inability to adequately monitor events. For benazepril, "the information is insufficient for the evaluation of safety. And since it's insufficient for the evaluation of safety and, if anything, there appear to be lot of potential for adverse events...I would think it deserves increased attention," committee member Mary Glode (University of Colorado) said at the Feb. 14 meeting in Rockville, Md. The Best Pharmaceuticals for Children Act requires FDA to present to the Pediatric Advisory Committee a report on adverse events for the first year of a product's marketing following granting of pediatric exclusivity. The committee expressed a similar concern for the monitoring of Baxter's cardioselective adrenergic receptor blocking agent Brevibloc (esmolol). "Esmolol...raises a real question in my mind how much information do we even have? If we've only seen 50 or 100 or 150, we have small chances of picking [up] some of the rarer" possibly fatal events, committee member Judith O'Fallon (Mayo Clinic) said. The advisory committee agreed with FDA's assessment that Roche's obesity treatment Xenical (orlistat) requires continued monitoring. "There were reports of cholelithiasis during the trial and in post-market surveillance, and we don't know what relationship between drug treatment or the rapid weight-loss and perhaps the obesity to begin with is," Division of Pediatric Drug Development Medical Officer Hari Sachs said. "We would recommend continued monitoring of this product." The committee also recommended that the agency analyze claims databases to improve the utility of FDA's reporting system for pediatric adverse events (1 (Also see "Pediatric Adverse Event Reporting Could Improve With Claims Database Analysis" - Pink Sheet, 15 Feb, 2005.)). [Editor's Note: To 2 watch a webcast or order a video/DVD of this advisory committee meeting, visit FDAAdvisoryCommittee.com]. - Andrew Shelton |