FDA Official Says Cardiovascular Risks Linked to Vioxx Might Not Apply to All COX-2 Inhibitors
The increased risk for heart attacks and strokes that prompted Merck last month to withdraw from the market the arthritis medication Vioxx, a COX-2 inhibitor, might not apply to similar treatments, according to Janet Woodcock, acting deputy commissioner for operations at FDA, the Wall Street Journal reports.
"At this point, we don't have any definitive evidence" that the cardiovascular risks linked to Vioxx apply to all COX-2 inhibitors, Woodcock said on Monday at the annual meeting of the American College of Rheumatology in San Antonio. She added, "We are far from understanding the complex mechanisms that may lead to this toxicity" (Hensley, Wall Street Journal, 10/19).
Woodcock also said that physicians must "evaluate the data and make benefit/risk decision for patients" when they decide whether to continue to prescribe COX-2 inhibitors to patients (Schwab, Newark Star-Ledger, 10/19). According to Woodcock, any new COX-2 inhibitors would receive "careful scrutiny" from FDA (Wall Street Journal, 10/19).