Pfizer admits Bextra increases heart attack risk in some patients

• Drug manufacturer Pfizer said Friday 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.
• Dr. Lee Simon, a rheumatologist with Boston-based Beth Israel Deaconess Medical Center and a former divisional director at the Food and Drug Administration's (FDA) Center of Drug Evaluation and Research, has studied COX-2 inhibitors.
• 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.
• But Pfizer said it had reviewed heart attack risk in rheumatoid arthritis and osteoarthritis patients and saw no increased heart attack risk in patients taking the drug from six to 52 weeks.