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Public Citizen Sues FDA Over Keeping Dangerously High Dose Aricept


The consumer advocacy group, Public Citizen, has filed a federal complaint against the U.S. Food and Drug Administration (FDA) to have the higher dose of the Alzheimer’s drug, Aricept, taken off the market because of the risk of fatal complications. The group made the first request 15 months ago and is now asking the court to order a decision by the federal agency. The complaint specifies the 23 mg dose of Aricept as putting the public at risk of suffering complications including death.

Aricept, also known as donepezel, is made by Eisai Co. and marketed by Pfizer. Courthouse News reports the FDA approved the 5 and 10 mg dosage in 1996. By 2009, the drugmaker petitioned the FDA to approve a 23 mg per day dose which was finally approved in July 2010.

Public Citizen says that decision represents an increased risk while offering nothing more effective. Bloomberg reports on May 18, 2011 Public Citizen asked the agency to pull the higher dose Aricept from the market and to add a warning about “increased toxicity associated with higher dosages.”    

The agency has “acted unlawfully by withholding action on Public Citizen’s petition,” says the complaint.

The higher dosage is associated with vomiting, gastrointestinal bleeding, and pneumonia; something a patient already compromised may not survive.

“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,” says the complaint.

The director of the FDA’s Division of Neurology Products approved the higher dose, despite recommendations from his staff against it, reports Courthouse News.

We recently got a look inside the workings of the FDA from 21 whistleblowers who went public with allegations that they were pressured to approve drugs even when the science could not assure public safety.

Twenty-one whistleblowers who were scientists within the FDA, have said their private computer conversations were monitored with spy software and they faced resistance when they voted against a drug or device approval such as imagine devices for mammograms and colonoscopies that exposed patients to excessive radiation. Some scientists were dismissed, others demoted.

The FDA has yet to act on additional warnings to consumers about the higher doses.

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