Petition Asks FDA to Pull Aricept High Dose Version from the MarketMay 19, 2011 | Parker Waichman LLP
A leading consumer advocacy group says the highest dose of the Alzheimer's treatment Aricept (donepezil) is dangerous and ineffective, and should be removed from the market. Public Citizen has filed a petition with the U.S. Food & Drug Administration (FDA) asking that the 23-milligram (mg) dose version of Aricept be pulled from the market immediately. A prominent geriatrician from Johns Hopkins University School of Medicine has joined Public Citizen in advocating for the removal of the drug.
“Data show that the 23-mg dose of donepezil is significantly more toxic than the 10-mg dose,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a statement announcing the petition. “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its lack of improved clinical benefits, this leads to only one conclusion: that the 23-mg dose should be immediately withdrawn from the market.”
Aricept is available in doses of 5 to 10 milligrams for patients with mild to moderate cases of Alzheimer’s disease. The 23-mg dose is approved for severe cases of the disease. In addition to seeking the withdrawal of the higher dose Aricept, the Public Citizen petition asks the FDA to warn doctors and patients against taking 20 mg of the drug (two 10-mg pills) a day.
Public Citizen pointed out that the only clinical trial of Aricept 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.
Side effects from the 23 mg dose Aricept compared to the 10-mg dose include a slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia. Vomiting occurred 3.5 times more often with the 23 mg dose. According to Wolfe, Aricept is particularly dangerous for Alzheimer’s disease patients because it can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death.
Public Citizen filed its petition jointly with 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.
“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," Finucane said in Public Citizen's statement.