Consumer Group Says High Dose Aricept Too Risky to Stay on the Market

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A prominent organization is advocating immediate removal of the high-dose version of Alzheimer’s drug Aricept from the market.  Public Citizen filed a petition today with the Food and Drug Administration (FDA) stating the drug should be removed because of its risks of serious side effects and its lack of effectiveness.

Donepezil, also known as Aricept, was approved by the FDA in doses of 5 to 10 milligrams (mg) and 10 to 23 mg.  The 5 to 10 mg dosage is for patients with mild to moderate cases of Alzheimer’s disease, while the 10 to 23 mg dosage is for patients with moderate to severe Alzheimer’s.

Public Citizen is requesting removal of the 23-mg dose alleging the dose is significantly more toxic than the 10-mg dose.  Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said, “Data show that the 23-mg dose of donepezil is significantly more toxic than the 10-mg dose.”

ConsumerAffairs.com reported that 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, 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.”

A clinical trial submitted to the FDA requesting approval of the 23-mg dose included a comparison to the 10-mg dose, says ConsumerAffairs, and yielded no results that the higher dose was more effective.

The trial revealed no significant difference between the two doses.  Three of four tests showed no difference in patients, on either cognitive or functional levels.  The fourth test only showed a two-point improvement over the 10-mg dose, which Dr. Finucane considered “not clinically important.”

The increased adverse effects of the 23-mg dose are a slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia.  Vomiting occurred more than 3.5 times as often in patients taking the 23-mg dose than the 10-mg dose.  Wolfe noted that vomiting is a dangerous side effect because it can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture and death.

“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,” said Wolf.

Dr. Finucane is also a co-petitioner with Public Citizen to ban the Aricept 23-mg dose.