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Stop selling higher dose Alzheimer's drug, group says
May 18th, 2011
05:05 PM ET

Stop selling higher dose Alzheimer's drug, group says

A specific dose of Alzheimer’s drug should be pulled from the market because it poses a risk to patients, according to a consumer  group.

The drug, donepezil, sold under the brand Aricept, is administered in several doses – the highest being 23 milligrams – for patients with moderate to severe Alzheimer’s disease.

It is prescribed to improve mental function, such as memory, attention and reasoning by increasing a brain chemical. Aricept which is taken daily,  could slow the mental decline, but it does not cure or prevent Alzheimer's. 

The Public Citizen’s Health Research Group called the 23-milligram dose of Aricept “significantly more toxic” than the 10-milligram dose and said it  “should be immediately withdrawn from the market.”

The group says that the drug in higher dose compared with the 10-milligrams could pose increased adverse effects such as slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness and agitation.  The group also said the higher dose does not appear to give any benefits to the patients.

Three stages of Alzheimer's

Patients often stop taking the higher dose because of its strong side effects such as vomiting. And Alzheimer’s patients are particularly sensitive to vomiting because it can lead to other problems such as pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death, the group said.

In response, Pfizer, which co-promotes Aricept with another company, Eisai, wrote in an emailed statement: "We are reviewing the petition and will respond accordingly; however, it is important to note that the Aricept (donepezil HCl) 23 mg tablet has been approved by the U.S. Food and Drug Administration for the treatment of moderate-to-severe Alzheimer’s disease. "

Dr. James Lah, director of the cognitive neurology program at Emory University"s Department of Neurology, regularly prescribes Aricept to patients, but doesn't prescribe the 23-milligram dose.

“Being Americans, the notion is that bigger is better, more is better... it’s simply not true in this particular instance,” Lah said.

He said he was concerned when the FDA approved the 23-milligram version.

“There is very little evidence that it’s superior,” Lah, an Alzheimer's clinician and associate professor said.  “There is a lot of evidence that it’s worse in terms of causing side effects.  If you look at the one study, only one clinical trial reported about the 23 versus 10 milligram Aricept. The results were entirely mixed in terms of effectiveness.”


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    December 10, 2020 at 16:52 | Report abuse | Reply
  48. Davidssasw

    issue, but a considerable financial burden brought on by cancer treatment. Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that,” said Sang-Jin Pak, Senior Vice President and Head of Commercial
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    Division, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening the availability of approved treatments for cancer patients across the US. In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab
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    products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not Sales of electronic-cigarettes could be halted if companies don't
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    December 10, 2020 at 16:54 | Report abuse | Reply
  49. Davidssasw

    reckon it's worth experimenting to find the minimum dose you can get away with Works pretty well. I have tried Levitra and the quick tab version also with not much positive results. Nonetheless I was given a prescription by my doc for this and for me
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    100 mg is the right dose. I can achieve erection but have at times a problem keeping it so this medicine will allow me to complete the act and enjoy it for a
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    few too without orgasming too quick. It's a wonderful medicine that I can get generically (legitimately) and save some money also so shop around. I have minimal side effects at first. What I mean is 4-5 hours after take it I notice a somewhat rapid heartbeat and some head flushing also but its well worth it as once again for me at least for some reason the
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    December 10, 2020 at 16:55 | Report abuse | Reply
  50. Davidssasw

    ago. I do have retrograde ejaculation due to needing Flomax for urinary problems but there have been no side effects from the combination. Both of us miss
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    the feeling of ejaculation but the long lasting erection makes up for the issue It is an wonderful drug but getting the dosage right is critical. I can still get an erection without
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    help but it had become a bit unreliable. I started off taking half a 50mg tablet . It certainly worked but I felt it was just a bit too much. I now cut tablet into 4 and find a quarter of a tablet
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    December 10, 2020 at 16:57 | Report abuse | Reply
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