FDA committees vote to change dosing of
acetaminophen p 92
With oral analgesic concerns, arthritis sufferers could
turn to external remedies p 92
Dr. Scholl’s steps it up with free foot assessments p 92
Local governments push to make PSE Rx-only p 94
Baby care suppliers target Hispanic community p 94
Products p 96, 97
Drug Store News
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August 10, 2009 • 91
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Health Care
92 • August 10, 2009
www.drugstorenews.com
Drug Store News
FDA committees vote on
dosing of acetaminophen
By Michael Johnsen
Three Food and Drug
Administration advisory
committees voted on
sweeping changes regarding
the marketing, merchandising
and formulation of acetamino-
phen products last month,
though the proposed changes
fell short of pulling combination
products containing acetamin-
ophen off the market.
Among the changes: Com-
mittee members recommend-
ed by a vote of 21-16 that the
maximum total daily dose of
4 g/day of acetaminophen in
nonprescription single-ingredi-
ent and combination products
be lowered; 24-13 recom-
mended the maximum non-
prescription single adult dose
be limited to 650 mg; 26-1 rec-
ommended that acetamino-
phen doses above that be
reverse-switched to prescrip-
tion-only; and 36-1 suggested
that only one strength of acet-
aminophen in liquid form be
available over the counter.
However, advisory commit-
tee members recommended
against imposing pack-size
limitations on products con-
taining acetaminophen (17-
20); and the committee also
did not support the recall of
OTC acetaminophen combi-
nation products (13-24).
There is still some question,
CONTINUED ON PAGE 96
With oral analgesic concerns, arthritis
sufferers could turn to external remedies
Achallenge for one category oftentimes
serves as an opportunity for another.
When Vioxx and other cox-2 inhibitors
were pulled off the market, arthritis patients
were forced to explore such alternative pain-
relief solutions as acetaminophen. But now with
safety