Consumer Group asks FDA to ban high doses of Alzheimer’s drug

FDA Should Ban High Doses of Alzheimer’s Drug Aricept, Public Citizen Says

May 19, 2011

Public Citizen has petitioned the Food and Drug Administration to ban high doses of the Alzheimer’s disease drug Aricept, claiming its risks far exceed its benefits.

The drug, made by Pfizer and Eisai, has been approved at doses of 5 to 10 milligrams for patients with mild to moderate Alzheimer’s disease, and at doses of 10 to 23 milligrams for more severe cases.

The consumer advocacy group Public Citizen says that the side effects of the higher dose, which include slowed heart rate and vomiting, negate its modest advantage over the lower dose. But given the dearth of effective Alzheimer’s treatments, some doctors believe the higher-dose option should stay on the table.

“In my opinion, it should be up to the consumer to decide whether to use this modestly effective, higher dose formulation of this drug,” said Dr. Steven Ferris, executive director of the Alzheimer’s Disease Center at New York University’s Langone Medical Center. “Are there better treatments available? Clearly not at the present time.”

Read the full article here: ABC News online.

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