If the goal were healing instead of profit these drugs would not have been marketed yet
FDA Advisors OK Disputed Pain Relievers
Medical experts acknowledge that the drugs, including Vioxx and Celebrex, pose dangers. They call for stronger warnings.
By Ricardo Alonso-Zaldivar and Denise Gellene
Times Staff Writers
February 19, 2005
WASHINGTON A Food and Drug Administration advisory panel voted Friday to let doctors prescribe Cox-2 painkillers, including Celebrex and Vioxx, but recommended stronger warnings about the risk of heart attacks and strokes.
Doctors, scientists and other experts on the 32-member panel overwhelmingly agreed that Cox-2 inhibitors hailed as a breakthrough in treating severe arthritis pain when they first won FDA approval all significantly increased the risk of cardiovascular problems in patients.
The panel proposed that Celebrex, Vioxx and Bextra, the third Cox-2 drug cleared by the FDA, carry "black box" warnings the strongest admonishment the FDA can give to doctors. Such warnings are likely to discourage use of the drugs.
The panel's decisions, made during three days of hearings and deliberations, sought to balance the health risks against the benefits the drugs provide to tens of millions who take them. In what amounted to a series of split verdicts, panel members divided over the risks posed by individual drugs in the Cox-2 inhibitor group.
