September 5, 2012 — Public Citizen, a consumer safety advocacy group, is suing the U.S. Food and Drug Administration (FDA) for failing to address safety concerns with high-dose Aricept, a popular Alzheimer’s disease medication. In May 2011, Public Citizen petitioned the FDA to remove 23-mg doses of Aricept from the market. The FDA has not responded, and Public Citizen now accuses the FDA of “foot-dragging” on the issue.
Public Citizen is particularly concerned that research indicates that high-dose Aricept does not control the symptoms of moderate/severe Alzheimer’s disease any better than lower-dose Aricept. Unfortunately, higher doses may increase the risk of life-threatening side effects. Public Citizen warned that high-dose Aricept can cause vomiting, which in Alzheimer’s patients “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.” The higher doses are also associated with an increased risk of nausea, diarrhea, anorexia, and confusion.
The group has requested that the FDA remove the 23-mg dose of Aricept from the market. Furthermore, they want a Black Box warning about high-dose side effects on 5-mg and 10-mg Aricept.
Public Citizen claims that Japanese pharmaceutical company Esai Co. Ltd. sought approval of 23-mg Aricept just before their patent on 5-mg and 10-mg Aricept was set to expire. As a condition of the approval, the FDA requested that the drug company conduct safety studies. According to Public Citizen, the study failed to show the higher doses had any “clinically meaningful benefit” over the lower-doses of the drug. An FDA medical reviewer also found the higher doses lacked any benefit, and recommended against approval of the drug. However, the FDA decided to approve 23-mg Aricept.
Since the approval of high-dose Aricept in 2010, the drug has sold well. Public Citizen said, “During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23.” The group is concerned that many people who use high-dose Aricept are unaware of the risks.
The lawsuit was filed in federal court in Washington. Attorneys for Public Citizen are requesting that the Court find the FDA’s lack of action on the matter unlawful. They also want the Court to require the FDA respond to the group’s petition within 30 days. They are requesting compensation for attorneys’ fees and reasonable expenses.
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