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November/December 2012
Public Citizen News
By Jake Parent
After dragging its feet for more
than a year, the U.S. Food and
Drug Administration (FDA) in No-
vember denied Public Citizen’s
petition asking that the Alzheim-
er’s disease drug Aricept 23 not
be marketed because of its unsafe
dosage levels.
The FDA’s decision came after
Public Citizen filed a lawsuit in
September requesting that the
United States District Court for
the District of Columbia force the
FDA to respond to the petition,
which Public Citizen had sent to
the FDA in May 2011.
The petition asked that the
agency immediately remove from
the market the 23-milligram (mg)
dose of Aricept and add warnings
to lower-dosage (5 mg and 10 mg)
forms of Aricept and its generic
counterpart, donepezil, against
use at a higher dosage. The peti-
tion argued that the higher dose
was barely more effective than
the previously available low-dose
versions, but far more dangerous.
Aricept was approved in 1996 as
a treatment for Alzheimer’s dis-
ease, the leading cause of demen-
tia in the U.S., at a dose of 5 or 10
mg daily. Before the drug’s pat-
ent expired in November 2010,
the drug maker, Eisai, sought ap-
proval for a 23-mg version, which
would allow the company to have
an additional period to market
the drug at the higher dose with-
out generic competition.
Without competition from ge-
neric versions of the drug, Eisai
can charge much higher prices
for the medication. During the
past year alone, approximately
672,000 prescriptions have been
filled in the U.S. for Aricept 23,
with total sales of $172 million.
A study presented to the FDA
by Eisai in 2009 failed to show
that the 23-mg version was more
effective than the lower-dose
drug in improving overall patient
function while showing it to be
only minimally more effective in
improving cognition. However,
the study also showed that the
higher dosage was associated
with a much higher incidence of
vomiting, which, in patients with
Alzheimer’s disease, can lead to
pneumonia, massive gastrointes-
tinal bleeding, esophageal rup-
ture or death, according to the
FDA.
Based on the study results,
the primary medical reviewer at
the FDA recommended that the
agency deny the company’s ap-
plication to market the 23-mg
version of the drug. That recom-
mendation was rejected by the
director of the FDA’s Division of
Neurology Products, Dr. Russell
G. Katz. The approval allowed Ei-
sai three years of exclusive mar-
keting rights for Aricept 23.
“A primary function of the FDA
is to protect citizens from harm
caused by needlessly danger-
ous drugs, in this case a drug no
more effective but significantly
more dangerous than the lower
doses of Aricept,” said Dr. Sid-
ney Wolfe, director of Public
Citizen’s Health Research Group.
“By denying Public Citizen’s peti-
tion, the agency has ignored this
responsibility and instead sup-
ported the profit interests of a
large pharmaceutical company.
Allowing Eisai to exploit and
potentially harm vulnerable pa-
tients with Alzheimer’s disease is
unconscionable.”
For more information, visit
http://pubc.it/QoSv3X.
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FDA Rejects
Public Citizen
Request for Ban
Of Aricept 23
Public Citizen’s petition
asked that the agency
immediately remove
from the market the
23-milligram (mg)
dose of Aricept and
add warnings to
lower-dosage (5 mg
and 10 mg) forms of
Aricept and its generic
counterpart, donepezil,
against use at a higher
dosage.