Vioxx Successor Arcoxia May Have Similar Heart Attack Risks

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Main Category: Arthritis
Also Included In: Pain / Anesthetics;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Sep 2006 - 8:00 PDT

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Arcoxia, a new experimental painkiller Merck & Co hope will become the successor of Vioxx, which was taken off the market because of its heart attack risks, may have similar risks, say scientists who looked at 23 clinical trials comparing several painkillers.

You can read about this new report in JAMA (the Journal of the American Medical Association).

In fact, the report showed that Vioxx and diclofenac carried similar cardiovascular risks (diclofenac is a much older painkiller). According to a Merck study, Arcoxia and diclofenac (Voltaren) have the same risks.

Vioxx raises cardiovascular risk by approximately 35%, diclofenac raises cardiovascular risk by about 40%. Voltaren (diclofenac) is currently sold in 62 countries.

By arguing that Arcoxia is no worse than diclofenac will not logically get it approved by the FDA if Vioxx and diclofenac carried similar risks. Arcoxia has already been turned down by the FDA (2004) because of insufficient safety data.

If you found the information above confusing, perhaps the alternative explanation below may make it clearer.

1. Vioxx was taken off the market some time ago because of heart attack and stroke risk.

2. Voltaren (diclofenac) is still sold in 62 countries and has similar risks to Vioxx.

3. Merck compares Arcoxia, a new experimental drug, to diclofenac, saying Arcoxia has similar risks. As the drug is still on the market it is saying Arcoxia is not more dangerous than a drug which is still on the market.

4. Why would the FDA approve Arcoxia if it has similar risks to diclofenac, which has similar risks to Vioxx?

"COX-2 Inhibitors, Other NSAIDs, and Cardiovascular Risk"
"The Seduction of Common Sense"
David J. Graham, MD, MPH
JAMA. 2006;296:(doi:10.1001/jama.296.13.jed60058).
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Written by: Christian Nordqivst
Editor Medical News Today


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