Consumer group Public Citizen filed a lawsuit requesting that the FDA withdraw a higher dose of Eisai and Pfizer's Alzheimer’s disease drug Aricept (donepezil) from the US market due to severe side effects. The group cited a study showing that the 23-milligram dose of Aricept was no more effective than lower doses yet was linked with a much higher incidence of vomiting.
The suit follows a petition filed by Public Citizen last year urging the FDA to remove the higher dose of Aricept from the market and add warnings to lower-dosage forms of the product and generic versions against use at a higher dosage. In December, the agency said it had yet to reach a decision on the group’s request because of the "significant issues" raised in the petition. In the lawsuit, Public Citizen is asking that the court "declare unlawful" the FDA’s failure to act on the petition and force the regulator to issue a decision.
Shortly before the US patent on Aricept expired in November 2010, the FDA cleared a 23-milligram dose of the drug, giving Eisai and Pfizer an additional three years of market exclusivity on the higher dose. Sidney Wolfe, director of Public Citizen’s Health Research Group, noted that "during the past year alone approximately 350 000 prescriptions have been filled in the US for Aricept 23, with total sales of $91 million."
FDA spokeswoman Sandy Walsh said the regulator doesn’t comment on pending litigation, while Eisai spokeswoman Marcia Diljak remarked that the company stands by the agency's "decision to approve Aricept 23 milligram as a safe and effective treatment of moderate-to- severe Alzheimer’s disease."
Earlier this year, an article in the BMJ challenged the FDA's approval of the higher dose of Aricept, noting that it offers "no meaningful added benefit, just more harm."
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