September 5, 2012 — The consumer advocacy group Public Citizen has filed a lawsuit against the U.S. Food and Drug Administration (FDA) for what it calls “foot-dragging” on addressing safety concerns with Aricept, a popular medication used to treat Alzheimer’s disease. Public Citizen filed a petition in May 2011 asking the FDA to withdraw the highest dose of Aricept.
According to Public Citizen, the problem is that researchers have found that high doses of Aricept are no more effective than low doses for controlling symptoms of moderate to severe Alzheimer’s disease. However, high doses of Aricept are associated with an increased risk of serious side effects — including vomiting, which Public Citizen warns “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.” High doses of Aricept have also been linked to anorexia, confusion, nausea, diarrhea, and other side effects.
Public Citizen is asking for the 23-milligram dose of Aricept to be withdrawn from the market. They are also asking the FDA to place a Black Box warning about high-dose side effects on lower-dose Aricept, which is sold in 5-mg and 10-mg doses.
The lawsuit alleges that Japan’s Eisai Co. Ltd. gained FDA approval for the 23-mg dose just as the patent was set to expire on the 5-mg and 10-mg doses. The FDA allegedly asked Eisai to conduct additional safety studies, but the study failed to show any “clinically meaningful benefit” over the lower doses of the drug. Due to the lack of benefit, an FDA medical reviewer recommended against approving high-dose Aricept. However, the reviewer’s objections were overruled, and 23-mg Aricept was approved.
According to Public Citizen, “During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23.”
The lawsuit has been filed in federal court. Public Citizen is requesting that the court find the FDA’s actions unlawful, and furthermore they want the FDA to respond to their petition within 30 days. They are also asking for attorneys’ fees and other reasonable costs.
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