FDA Approved Aricept 23 Despite Warnings

Alzheimer’s patients and their caregivers should be outraged by the Food and Drug Administration’s approval of a higher dose of a popular Alzheimer’s drug, despite evidence that the dosage causes dangerous side effects in patients and only boosted their memory function slightly.

The approval decision “breached the FDA’s own regulatory standard” and led to “incomplete and distorted messages” about Aricept 23 (donepezil), according to an article published this month in the British Medical Journal by two professors at the Dartmouth Institute for Health Policy and Clinical Practice.

Dr. Lisa Schwartz and Steven Woloshin said the higher Aricept dosage was approved in 2010 over objections from the agency’s own medical and statistical reviewers. The reviewers opposed the approval after the failure of a clinical trial that was meant to show the higher dosage met the goal of improving cognitive and overall functioning in Alzheimer’s patients, according to The New York Times.

The study of 1,400 Alzheimer’s patients found that the higher dosage led to significantly more vomiting and nausea but only slight improvement on cognitive function and no impact on overall function. However, the FDA concluded that the higher dosage would benefit patients suffering from Alzheimer’s disease, even though the results of the study did not appear to support that.

Interestingly, the approval came as the patent for Aricept was about to expire. Applying for a new dosage on an existing drug is one way to extend a company’s exclusive right to sell and maintain an advantage over generic versions.

Schwartz and Woloshin also found that the drug makers made false claims about the benefits of Aricept 23 on the drug label and in its advertisements. When they alerted the FDA of this, the agency said that it was an oversight and the label was corrected.

If you or a loved one has been harmed by Aricept or another dangerous drug, contact Sokolove Law for a free legal consult and to find out if a dangerous drug lawyer may be able to help you.