The FDA has denied Public Citizen’s appeal for a ban on the 23-mg dose of Eisai’s Alzheimer’s drug Aricept. The higher dose has shown added benefits over lower doses, improvement that may justify the risk of additional side effects, the agency said. A request to add a warning to Aricept (donepezil) 5-mg and 10-mg versions stating that “use of 20 milligrams per day is counter indicated” was also shot down.
Washington Drug Letter