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Vioxx's cousin may hold its risks

By GRAHAM BRINK
Published November 14, 2006

Two years ago, Merck & Co. pulled its blockbuster painkiller Vioxx from the shelves for heart safety reasons.

The company now hopes to recapture part of the U.S. market with Arcoxia, a cousin to Vioxx already available in 62 countries.

But the results of studies released Monday have some critics urging the Food and Drug Administration not to approve Arcoxia. They say the studies were flawed and the risks too similar to Vioxx.

A lot is on the line: Tens of millions of Americans regularly use anti-inflammatory painkillers for arthritis and other ailments.

What is Arcoxia?

Like Vioxx, Arcoxia is a Cox-2 selective inhibitor. They were developed to be gentler on the stomach and easier to take long-term than traditional pain relievers like ibuprofen.

What were the studies based on?

They looked at 34,701 arthritis patients with an average age of 63 from the United States and 37 other countries. Roughly half received Arcoxia and half took diclofenac, an older painkiller sold as Cataflam and Voltaren. Patients spent an average of 18 months on the drugs.

What did the studies find?

The rate of clot-related heart problems, heart attack, stroke and cardiac death were similar among the two groups even as Arcoxia users were 30 percent less likely to have ulcers, stomach bleeding or other gastrointestinal problems. Congestive heart failure was rare but more common among those receiving a higher dose of Arcoxia than among those on a lower dose or diclofenac.

What is the controversy?

The critics point out Arcoxia's side effects and that it was tested against diclofenac, which is known to raise heart risks. A better comparison, they say, would be with a drug like naproxen, sold as Aleve, a painkiller with a relatively low cardiovascular risk compared with other painkillers.

"The development program for Arcoxia is fatally flawed," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who formerly headed the FDA's cardiac drug advisory panel. "My advice to the FDA is that they should not approve this drug."

"There's every reason to think it suffers from the same problems" as Vioxx, said Dr. David Graham, an FDA drug safety expert who has criticized his agency's handling of Vioxx.

What is Merck saying?

The Arcoxia studies aren't "the answer to everything" about painkillers, but they provide one piece of the puzzle, said the lead author, Dr. Christopher Cannon of Brigham and Women's Hospital in Boston. Merck commissioned Cannon and his colleagues to conduct the studies.

"A picture is emerging here," said co-author Garret FitzGerald, a University of Pennsylvania scientist who believes that all Cox-2 drugs bring additional heart and stroke risks because they work through a common mechanism.

Patients at risk of heart disease should stay away from drugs like Arcoxia, FitzGerald said. Conversely, for patients at risk for ulcer or stomach bleeding, such a drug might make more sense, he said.

Are there any other Cox-2 drugs available?

Pfizer's Celebrex is the only one on the U.S. market.

Why not just use Aleve?

In many cases, it is not as effective at fighting arthritis in the long-term, and it has its own side effects.

What's next for Arcoxia?

Last week, the company said it would narrow its request from a wide range of ailments to treating symptoms of osteoarthritis. Merck expects the FDA review to take until April.

Where were the Arcoxia studies published?

In the British journal the Lancet. They also were presented at a meeting Monday in Chicago of the American Heart Association.

How did the news of the studies affect Merck's stock price?

It rose 34 cents on Monday to close at $43.46 on the New York Stock Exchange.

What's the status of Vioxx?

It is no longer sold in the United States. Merck pulled the drug in September 2004 after a study found a greater risk of heart attack in people who had taken the drug continually for at least 18 months. Soon after, Merck hoped to bring Vioxx back with tougher restrictions.

The company, which sold almost $3-billion of Vioxx a year, set aside more than $1.2-billion to fight the 14,200 pending lawsuits nationwide. As of September, Merck had won five of the lawsuits and lost four.

Information from Times wires was used in this report.

[Last modified November 14, 2006, 01:30:58]