High Dosages Of Alzheimer's Drug Aricept Ban, Watchdog Pushes FDA

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Main Category: Alzheimer's / Dementia
Article Date: 19 May 2011 - 10:00 PDT


The FDA is under pressure to ban studied high dosages of Aricept, a drug used to treat moderate or severe cases of Alzheimer's disease (AD) because of its risk of serious adverse effects and its lack of effectiveness according to a national watchdog organization named Public Citizen with support from a Johns Hopkins doctor who specializes in geriatric medicine, giving the request merit.

Dr. Thomas Finucane, professor of medicine in the Division of Gerontology and Geriatric Medicine at The Johns Hopkins University School of Medicine and staff physician at the Johns Hopkins Bayview Medical Center explains:

"Cholinesterase inhibitors such as Aricept have gained multibillion-dollar success due primarily to two factors: the understandable desperation of those who care for patients with Alzheimer's disease, and a relentless promotional campaign by drug companies. When clinicians consider whether to initiate a therapeutic trial of a largely ineffective drug, the risk of harm should be a prominent consideration. The clearly increased risk of harm from Aricept 23-mg compared to Aricept 10-mg is so great, coupled with the lack of any evidence of improved benefit, that I believe it should not have been approved for sale to the families and caregivers of Alzheimer patients."

Ok wait. So what is Aricept, aka donepezil? Donepezil is in a class of medications called cholinesterase inhibitors. It improves mental function (such as memory, attention, social interaction, reasoning and language abilities, and ability to perform activities of daily living) by increasing the amount of a certain naturally occurring substance in the brain. Donepezil may improve the ability to think and remember or slow the loss of these abilities in people who have AD. However, donepezil will not cure AD or prevent the loss of mental abilities at some time in the future.

The drug had been approved by the FDA in a dose of 5 to 10 milligrams (mg) for patients with mild to moderate cases of Alzheimer's disease and in a dose of 10 or 23 mg for patients with moderate to severe Alzheimer's. Public Citizen is calling for the 23-mg dose to be immediately pulled from the market.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group states:

"Data show that the 23-mg dose of donepezil is significantly more toxic than the 10-mg dose. Combined with its lack of improved clinical benefits, this leads to only one conclusion: that the 23-mg dose should be immediately withdrawn from the market."

The only clinical trial of donepezil submitted to the FDA for approval of the 23-mg dose compared it to the 10-mg dose and failed to prove that the higher dose was more effective. In three of four tests, on either a cognitive or functional level, there was no significant difference between the 10- and 23-mg doses. In the fourth test, the improvement over the 10-mg dose was only two points on a 100-point scale, which is not clinically important Wolfe said.

Wolfe continues:

"With no evidence of an added advantage in benefit to patients, the clear increase in risk should have been more than adequate grounds for denying approval, a conclusion reached by both the FDA medical officer and statistician. It is inexcusable that the FDA approved this higher dose. Its prompt removal would belatedly fulfill the agency's mission to allow only drugs whose benefits outweigh their risks to be marketed."

Click HERE for the actual petition sent to the FDA.

Source: Public Citizen

Written by Sy Kraft


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