Advisory Panel Weighs COX-2 Inhibitors' Fate
Advisors to the Food and Drug Administration (FDA) last week recommended that "black box" warnings be added to the label of the two COX-2 inhibitors currently for sale in the United States, and to a third that might be reintroduced (rofecoxib, or Vioxx). The warnings would alert physicians and patients to an increased risk of cardiovascular events associated with the drugs' use. The risk, the committee agreed, represents a so-called class effect of COX-2 agents like celecoxib (Celebrex), valdecoxib (Bextra), and rofecoxib that were developed to alleviate pain while limiting gastrointestinal effects by blocking the action of the COX-2 enzyme.
Dr. Robert Temple, of the FDA Center for Drug Evaluation and Research, told committee members that the agency was "committed to working as quickly as possible" in considering and implementing the recommendations.
Although COX-2 inhibitors' primary indication is to treat pain associated with osteoarthritis and rheumatoid arthritis, the committee's recommendation to leave the drugs on the market means that at least celecoxib, which the committee almost unanimously agreed is the least likely to be associated with adverse cardiac events, can continue to be studied for use in the prevention and treatment of cancer. Both aspirin and COX-2 inhibitors have shown promise in preventing polyps that can lead to colon cancer. Read more
Guest Update by Dr. Robert Croyle
Health Information National Trends Survey Web Site Unveiled
Today, I am pleased to announce that a new HINTS Web site (http://hints.cancer.gov) expands access to HINTS data for multiple audiences, using tables, charts, population estimates, and technical history information on every question in the survey. The updated Web site reflects NCI's commitment to public data sharing by making the science of cancer communication easily accessible to multiple audiences. The new tools within the site were developed with extensive input from federal and private partners in cancer communication research and practice. Read more