Audience: Oncologists, particularly Pediatric Oncologists
Wyeth-Ayerst notifies health professionals of safety information for NEUMEGA use in the pediatric population. Preliminary data from a safety and pharmacokinetic study in 47 children has identified papilledema as a dose-limiting adverse reaction in the pediatric population. There are no controlled clinical studies that have established a safe and effective dose of NEUMEGA in children. Therefore, the administration of NEUMEGA in children, particularly those under 12 years of age, should be restricted to controlled clinical trial settings with closely monitored safety assessments. See the full letter below for further details.
[August 24, 2001 - Letter - Wyeth-Ayerst]