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11/9/2004 - BEXTRA LINKED TO HEART ATTACKS

Drug manufacturer Pfizer said recently that its Bextra drug, seen as an alternative to Merck's Vioxx arthritis medication, may raise heart attack risk in high-risk bypass surgery patients. Pfizer said that although clinical information on Bextra suggested no increased heart attack risk in arthritis patients, two trials in a high-risk surgery known as coronary artery bypass graft showed cardiovascular complications in patients who received Bextra alone or in combination with Parecoxib, a pain medication.

Additionally, the company said it is working with regulatory authorities to update the Bextra product label to warn of a rare but serious skin reaction, mainly within the first two weeks of therapy.The drug manufacturer said the risk of a serious skin reaction is higher with Bextra than with Pfizer's other arthritis medication, Celebrex.

Pfizer said Bextra is not approved for use in surgery in the United States and that the company was conducting further studies to confirm Bextra's long-term cardiovascular safety. However, Pfizer's Dynastat medication, an injectable COX-2 inhibitor and prodrug of Bextra, has been approved for use in surgical settings in Europe but not in the United States.

Bextra Recall

Earlier this month, Merck issued a worldwide recall of its blockbuster arthritis drug Vioxx after an ongoing trial confirmed the medication increases the risk of heart attack and strokes.


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