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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23-milligram dose of Aricept “significantly more toxic” than the 10-milligram dose and said it  “should be immediately withdrawn from the market.”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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  19. Davidssasw

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    a 78 percent increase in e-cigarette use by U.S. high school students, and 3.6 million high school and middle school students now use e-cigarettes, according to U.S. Centers for Disease Control and Prevention data released late last year, NBC News reported. Two Doctors Leave Care Facility Where Incapacitated Patient Gave
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  21. Davidssasw

    reported. A Chinese scientist who said he edited the genes of twins to protect them against HIV acted on his own and could face punishment, according
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    will be kept under medical observation through regular visits overseen by health officials, according to Xinhua. The news agency didn't specify which laws He may have broken, but said he faked an ethical review by others, the AP reported. This behavior seriously violates ethics and the integrity of scientific research, is in serious violation of relevant national regulations and creates a pernicious influence at home and abroad," according to Xinhua. After He announced
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  22. Davidssasw

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    Senior Vice President and Head of Commercial 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
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    incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab 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
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  23. Davidssasw

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    according to U.S. Centers for Disease Control and Prevention data released late last year, NBC News reported. Two Doctors Leave Care Facility Where
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    Incapacitated Patient Gave Birth Two doctors who provided care for an incapacitated woman who had a baby after being sexually assaulted are no longer looking after patients at the
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