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Warning on Cox-2 Drugs

The American Heart Association says they can increase the risk of heart damage and stroke.

The American Heart Association wants doctors to reduce their reliance on the class of pain relievers that includes Celebrex from


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and Vioxx from


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The association took aim at drugs known as Cox-2 inhibitors, saying research shows they can increase the risk of heart damage and stroke. Even though Celebrex is the only Cox-2 drug on the market, and it's subject to increased restrictions, the association says more vigilance is needed.

"We believe that some physicians have been prescribing the new Cox-2 inhibitors as the first line of treatment," says Dr. Elliott Antman, professor of medicine at the Harvard Medical School and Boston's Brigham and Women's Hospital. "For chronic pain in patients with known heart disease or who are at risk for heart disease, these drugs should be the last line of treatment."

Antman is one of six physicians and scientists who released recommendations for the association's members Monday after markets had closed. The guidelines were contained in an article posted in the online version of


, the association's scientific journal.

None of the authors has any financial link to makers of Cox-2 drugs or other pain relievers called nonsteroidal anti-inflammatory drugs, or NSAIDs. The latter group includes products such as ibuprofen and naproxen, and the authors say doctors should be more careful in prescribing those drugs, too.

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The authors say the first lines of defense in pain management should be physical therapy, exercise, weight loss and heat or cold therapy. If these treatments don't work, the first drug therapy should be aspirin, acetaminophen (the ingredient in Tylenol) or narcotic analgesics.

Cox-2 inhibitors should be the last therapy, "and all drugs should be used at the lowest dose necessary to control symptoms and prescribed for the shortest time possible," they say.

"This is a fast-moving field with new information available from multiple sources," Antman adds. "We feel the most important thing the American Heart Association can do is to give practical advice to clinicians who treat cardiac patients with pain every day."

The American Heart Association's recommendations, an update of guidelines issued two years ago, come as Celebrex is making a comeback and other companies are seeking FDA approval of Cox-2 drugs.

Celebrex produced sales of $2.04 billion last year, up from $1.73 billion in 2005. Celebrex peaked at $3.3 billion in 2004. Pfizer

withdrew the Cox-2 drug Bextra from the market in early 2005 after the FDA said the risks outweighed the benefits.

In the U.S., Celebrex is

approved for seven indications, including pain relief, osteoarthritis, rheumatoid arthritis and the reduction of certain colon polyps. The label contains "black box" warnings -- the FDA's strongest alert -- about the increased risk of cardiovascular damage, stroke and gastrointestinal problems. All NSAIDs carry similar warnings.


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plans to seek FDA approval this year for Prexige, which was

recently approved by the European Union. The drug is available in more than two dozen countries, including Canada and the U.K.

Merck's Vioxx cousin, Arcoxia, is available in more than 60 countries. Merck has predicted the

FDA would act by late April on its request for Arcoxia as a treatment for osteoarthritis. The company pulled Vioxx from the market in September 2004.