TRENTON, N.J. – A consumer group pressing the Food and Drug Administration to remove the highest dose of an Alzheimer’s disease drug from the market is suing the agency for what it calls “foot-dragging.”
Public Citizen said Wednesday that the FDA’s own medical and statistical reviewers found that high-dose Aricept doesn’t work better at controlling symptoms of moderate-to-severe Alzheimer’s than two low doses.
However, the group said the high dose has more-dangerous, potentially deadly side effects including vomiting, which in Alzheimer’s patients “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.” Other side effects more common at the high dose are nausea, diarrhea, anorexia and confusion.
Public Citizen filed a petition in May 2011 with the FDA. The group urged the agency to halt sales of the 23-milligram dose of Aricept and put safety warnings about the high-dose risks on two low doses, 5 and 10 milligrams. The low doses are available under both the Aricept brand, made by Japan’s Eisai Co. Ltd., and as generic pills.
The FDA has yet to act.
The lawsuit, filed in federal court in Washington, D.C., asks the court to declare the FDA’s failure to act unlawful and to order the agency to decide within 30 days of the court’s ruling whether to approve Public Citizen’s request.