8
PAC Meeting April 2007
Summary:  Orlistat
•Minimal use in pediatric patients
•Additional cases of cholelithiasis identified in adults
•Labeling reflects an increased risk of gallstone formation with substantial weight loss.
•FDA recommends routine monitoring of AEs for this drug in all populations.
•AE reporting for nonprescription products will be required in the near future.
•Does the Advisory Committee concur?