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Medsafe Coxib Review

Medsafe Coxib Review

Statement by Alister Brown, managing director, Merck Sharp & Dohme NZ (MSD):

“We recognize that the cardiovascular safety of the coxib and NSAID classes is an important public health issue. The data suggest an increased cardiovascular risk vs. placebo is a class effect. At the present time it is unclear if the class of drugs is limited to COX-2 selective inhibitors, all NSAIDs or NSAIDs without potent antiplatelet effects.

“There are risks and benefits with every drug, and COX-2s and NSAIDs are no different. It is important to recognize that the patients who continue to suffer with pain need effective therapies. Given the continuing need for effective pain therapy and the data currently available for ARCOXIA, we believe ARCOXIA is a suitable therapeutic option for appropriate patients in New Zealand.

“MSD currently has under way the largest arthritis trial ever conducted, called MEDAL, to assess the cardiovascular safety of ARCOXIA to the most widely used NSAID, diclofenac, in more than 23,000 patients worldwide.

“We received details of Medsafe’s preliminary assessment late on Friday. Medsafe has invited MSD to make further submissions in response to its preliminary finding, including additional data analyses and proposals for managing patient risk. MSD looks forward to working with Medsafe and contributing further to the evaluation of this class of drugs.”

Note to Editors: There are approximately 4000 New Zealand patients taking the MSD coxib ARCOXIA. When VIOXX was voluntarily withdrawn on 1 October 2004, there were approximately 12,000 New Zealand patients taking VIOXX.

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