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Brand name: Aricept

Public Citizen petitioned the Food and Drug Administration (FDA) to immediately remove from the market the 23 milligram (mg) dose of Aricept (donepezil; Eisai Co., Ltd; Pfizer Inc.) because in the primary clinical trial:

1) The 23 mg dose of Aricept failed to meet the two efficacy criteria required by FDA as a condition of approval of drugs for dementia, specifically required for Aricept 23 in this case.

2) The 23 mg dose of Aricept significantly increased adverse events compared with the previously approved 10 mg dose, including increased risks for nausea, vomiting, diarrhea, anorexia, and confusion.

3) The 23 mg dose of Aricept received negative reviews from both the FDA clinical and statistical reviewers.

More information on donepezil (Aricept)

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