Controversy over High Dose Aricept

Contributed by: Dennis Fortier, President, Medical Care Corporation

 A consumer advocate group is calling for a ban on the 23mg Aricept dosage, which was approved by the FDA for more severe stages of Alzheimer's.

While Aricept is the mostly widely prescribed drug for the treatment of AD, it is most commonly prescribed in 5mg and 10mg doses.  Its efficacy in controlling symptoms is only moderate, but it has been on the market for more than a decade and has a solid safety profile.  The more recently approved, higher dosage of 23mg has been associated with a higher incidence of side effects and, according to the advocacy group Public Citizen, has no greater efficacy.  The primary side effects are nausea, vomiting, and agitation.

It is unclear whether the FDA will act on the petition to review the data and reverse the former approval for this dosage.  However, the most salient point for treating physicians to understand is that, regardless of the dosage, cholinesterase inhibitors like Aricept yield the most clinical benefit when prescribed as poly-therapy along with Namenda.  The data supporting this clinical approach are clear and compelling.