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Merck supports Arcoxia, successor to Vioxx


Preparing for a scientific and regulatory legal battle, Merck says a large study has shown that a potential follow-up to its painkiller Vioxx is no more dangerous to the heart than an older painkiller still widely in use.
The Merck drug Arcoxia is sold in 62 countries, but not the United States.  This is because U.S. regulators have deferred action on the drug. Analysts have predicted that Arcoxia has little chance of approval because of concern that it might pose similar heart risks to those of Vioxx, which Merck withdrew from the market in 2004 over concerns for health safety.

Merck announced the results of the main study and indicated that it intended to crusade for approval to sell Arcoxia in the United States.

Some independent scientists criticized the company for making its announcement despite only releasing a portion of the study's details. It is also noted that of Arcoxia’s side effects divulged by Merck, high blood pressure was included.

Merck has almost $3 billion in sales of Vioxx one year before it withdrew the drug in September 2004 after a clinical trial study showed that Vioxx dramatically increased the risk of heart attacks and strokes in its users. Consequently, Merck faces more than 14,000 lawsuits from people who say they suffered heart damage after taking Vioxx.

Yet, a drug in the same class as Vioxx - Celebrex , made by Pfizer, still has annual sales of nearly $2 billion.  Celebrex’s annual sales are strong despite carrying a warning label that it, too, may pose heart risks.

Merck officials said the new study, which covered 34,000 patients, shows that Arcoxia's risks are comparable to the older painkiller, Diclofenac,

Diclofenac is a prescription drug sold under brand names such as Cataflam and Voltaren.  It is not popular in the United States, partially due to concerns that it causes liver problems.  However, it is widely used in Europe.

The President of the American College of Cardiology, Dr. Steven Nissen said Merck should have disclosed more information from the Arcoxia trial study or not discussed it at all. "They didn't really release enough data for us to make a conclusion," said Nissen, who manages a large clinical trial sponsored by Pfizer to study the heart risks of Celebrex.

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