Group Wants High-Dose Aricept off the Market

WASHINGTON (CN) - High-dosage pills of Aricept, an Alzheimer's drug, should be banned because of possibly fatal side effects, Public Citizen says in a federal complaint against the U.S. Food and Drug Administration.

Public Citizen asked the court to order the FDA to act on its more-than-15-month-old petition to ban 23 mg doses of the drug and relabel 5 and 10 mg doses.

"As long as the 23 mg dose of Aricept remains on the market, Public Citizen's members are at risk of suffering adverse effects of this drug, including death," the complaint states.

Aricept, or donepezel, is an acetylcholinesterase inhibitor used to treat Alzheimer's disease, the most common form of dementia suffered by millions worldwide. The drug is manufactured by Eisai Co., and marketed by Pfizer. The FDA approved the 5 and 10 mg doses of the drug in 1996.

In 2009, Eisai successfully petitioned the agency to approve a 23 mg per day dose of the drug, despite a study that higher doses of donepezel significantly increase risks of adverse effects while being no more effective than lower doses, Public Citizen says.

"In particular, the use of the 23 mg dose was associated with a much higher incidence of vomiting, which, in patients with Alzheimer's disease, can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture, or death," according to the complaint.

The director of the FDA's Division of Neurology Products, Dr. Russel Katz, approved the higher dose of Aricept despite recommendations against it from his staff, the group claims.

Public Citizen says it filed a petition to have the 23 mg dose dropped from the market and lower doses relabeled, to warn consumers of the side effects of higher doses, but the agency has yet to act.

"The considerable danger to public health caused by the FDA's failure to withdraw the 23 mg dose of Aricept from the market and to add a warning to the lower dose forms of the drug counsels in favor of expeditious action on Public Citizen's petition," the complaint states. "The pace of the FDA's decisional process is lagging unreasonably in light of the nature and extent of the public health interest at stake."

The Washington-based group says it has 300,000 members and supporters nationwide, and "promotes research-based, system-wide changes in health care policy and provides oversight concerning drugs, medical devices, doctors, hospitals, and occupational health." It also publishes a consumer guide titled, "Worst Pills, Best Pills News."

It wants the court to order the FDA to act on its petition.

Public Citizen is represented by staff attorney Michael Kirkpatrick.

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