WASHINGTON (AP) — 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 “foot-dragging.”
Public Citizen says the FDA’s own reviewers found that high-dose Aricept (AR’ih-sept) doesn’t work better than two low doses but has more-dangerous, potentially deadly side effects.
Public Citizen filed a petition in 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 available under the Aricept brand and as generic pills.
The FDA has yet to act. A spokeswoman says FDA doesn’t comment on litigation. Last December, the agency wrote to Public Citizen, saying it was doing a review of the case.