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Monday, May 23, 2011

Public Citizen Wants FDA to Ban Aricept 23

I found this article on the Dementia Weekly website. I cannot say that I agree since I have seen some dramatic results from taking Aricept 23. Yes, there are side effects, but most of the the side-effects go away after a few weeks. Why should some interfering pseudo do-gooders want to make it more difficult for those of us impacted by dementia to make our own decisions. Nobody is forcing anyone to take Aricept. We need to have more, not fewer, choices.  If it works for even a few of us it should be available.

They are not saying that Aricept does not work. They are just saying that there isn't a benefit to taking 23mg over 10mg. I must disagree. In my case I think I did see a difference. Of course Aricept is not approved for FTD anyway, so I guess that doesn't count.

WASHINGTON, D.C. – A drug used to treat moderate or severe cases of Alzheimer’s disease should be removed from the market immediately because of its risk of serious adverse effects and its lack of effectiveness, Public Citizen and an eminent geriatrician from Johns Hopkins said in a petition filed today with the Food and Drug Administration (FDA).

Donepezil, also known as Aricept, has 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.

“Data show that the 23-mg dose of donepezil is significantly more toxic than the 10-mg dose,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “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its lack of improved clinical benefits, this leads to only one conclusion: that the 23-mg dose should be immediately withdrawn from the market.”

Public Citizen is also asking the FDA to warn doctors and patients against taking 20 mg of the drug (two 10-mg pills) a day, even if Aricept 23 is removed from pharmacy shelves.

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, stated that “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.” Finucane is a co-petitioner with Public Citizen to ban Aricept 23.

“When clinicians consider whether to initiate a therapeutic trial of a largely ineffective drug, the risk of harm should be a prominent consideration,” Finucane said. “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.”

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.

Increased adverse effects of the 23-mg dose of donepezil compared to the 10-mg dose include a slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia. Vomiting – which occurred more than 3.5 times as often in patients taking the 23-mg dose than those taking the 10-mg dose – is a particularly dangerous side effect for patients with Alzheimer’s disease because it can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death, Wolfe said.

Overall, patients taking the 23-mg dose stopped taking the drug because of adverse effects more than twice as often as those taking the 10-mg dose. Additionally, because of the drug’s very long half-life, it can stay in patients’ systems for about two weeks after they stop taking the drug. So, those who suffered adverse effects may not have immediate relief after they stop treatment, Wolfe said.

“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,” Wolfe said. “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.”

Here is a video of this story.

Comments and questions are welcome.


  1. So what is the FDA's reaction to all this? In reading your posting, the first thing that came to mind is that Public Citizen's words could be applied to dozenss of different drugs on the market. My second thought is wondering who funds that organization and what thier agenda is. Interesting story though.

  2. A friend sent me the link to your posts. First off, I applaud you on keeping up with these posts. Your observations may very well help many other people now and in the future. It is obvious that you are well educated, some of the posts were "over my head" for sure.

    My 64 yr. old husband has Fronto Temporal Dementia. Tests indicate that he is probably two years into it. He lost all interest in golf, pool, computers, motor home trips, etc. Had bad impulse control such as walking into neighbors homes, etc. We tried Namenda and could see no results at all. The Neurologist now has him on Serequel and that has helped allot. He can once again watch a whole tv show and read magazine articles. No more problems with the neighbors for awhile either. His biggest concern each day is to eat, listen to music and sleep. Anything requiring more than a little concentration is avoided. Hard to get him to go anywhere or be interested in anything, but he is usually always in a good mood and doesn't think anything is wrong with him. That's sort of a blessing too.

    I am so impressed that you are on this "journey" and taking care of your own day to day living needs. I don't think my husband could manage on his own at all. Yes, I know it can be different for each individual.

    I keep praying that there will be breakthroughs with new medications. I'll be back to check your posts. God bless.