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 inexpensive generic pills.
The FDA has yet to act.
The lawsuit, filed in federal court in Washington, 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. The suit also seeks attorneys' fees and other reasonable costs.
"By ignoring Public Citizen's petition for more than a year, the agency has ignored (its) responsibility," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. "During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23."
"Allowing Eisai to exploit and harm vulnerable patients with Alzheimer's disease is unconscionable," Wolfe added.
An FDA spokeswoman said Wednesday in an email that the agency doesn't comment on pending litigation. Last December, the associate policy director in its Center for Drug Evaluation and Research, Jane Axelrad, notified Public Citizen the FDA was doing a detailed evaluation of the case.
"FDA has been unable to reach a decision on your petition because it raises significant issues requiring extensive review and analysis by agency officials," she wrote. "We will respond to your petition as soon as we have reached a decision on your request."
Marcia Diljak, a spokeswoman at Eisai's U.S. subsidiary, Eisai Inc. of Woodcliff Lake, N.J., said the company was aware of the complaint filed against the FDA but won't comment on the litigation.
"We stand by the FDA's decision" to approve high-dose Aricept as a safe, effective Alzheimer's treatment, she wrote in an email.
According to Public Citizen, Eisai sought approval of the higher Aricept dose ahead of the November 2010 expiration of the patents for the two low doses. The ensuing generic competition would have slashed their sales.
The lawsuit states that the FDA required the company to prove in a study that the high dose improved patients' mental and physical functioning, but the study failed to show the high-dose "has any clinically meaningful benefit."
That led FDA's medical reviewer to recommend against approving the high dose, but the head of FDA's division of neurology products decided to approve the product anyway, the lawsuit states. The high dose was approved on July 23, 2010, extending Eisai's patent protection for an additional three years, the suit notes.