News on Celebrex and Vioxx

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Title: Searle & Pfizer Refute Merck's Claims About Benefits Of Vioxx

URL: http://www.pslgroup.com/dg/E2CFA.htm

Doctor's Guide

June 10, 1999

CHICAGO, IL -- June 9, 1999 -- G.D. Searle & Co. and Pfizer Inc. have

refuted claims by Merck & Co. about the

pain-relieving benefits of Vioxx (rofecoxib), Merck's COX-2 inhibitor,

because conclusions were drawn from a

poorly-designed study, they say.

Searle and Pfizer, which co-promote Celebrex (celecoxib) said that

Merck's conclusions were erroneous because the company

used inequivalent doses when comparing Celebrex to Vioxx. Limited data

on the Merck study, a single-dose study in acute

dental pain, was made available during a medical meeting in Scotland

this week.

The study in question compared the lowest recommended dose for Celebrex

(200 mg per day) with the highest possible dose

of Vioxx (50 mg per day). Searle and Pfizer said they believe these data

are misleading because the maximum recommended

daily dose of Celebrex in the United States is 400 mg.

The 50 mg dose of Vioxx is not approved for use in the United Kingdom,

where the data were released. Prescribing

information in the U.S. indicates that the 50 mg dose of Vioxx carries a

higher incidence of gastrointestinal, renal and

cardiovascular side effects compared to the lower 25 mg dose. Further,

according to the approved prescribing information in

the U.K. patients should not receive more than 25 mg dose of Vioxx per

day. " The risks of gastrointestinal symptoms, oedema

or hypertension are increased, " the prescribing information states.

Celebrex is approved in the U.S. for the treatment of the signs and

symptoms associated with osteoarthritis and adult

rheumatoid arthritis. It is not currently licensed for sale in the

European Union.

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