FDA Issues New Warnings on Label for Bextra
12/10/2004
Editor's note: For the official SAA Position Statement on the COX-2 Inhibitors (Vioxx, Celebrex, Arcoxia, Bextra) please click here.
On December 9, 2004, the Food and Drug Administration (FDA) announced that Bextra, a COX-2 Inhibitor, a drug in the same class as Vioxx and Celebrex, would receive new warnings regarding cardiovascular risks as well as a "boxed" warning regarding possible serious skin reactions.
The warnings of cardiovascular risks come from a recently completed study done by the drug's maker, Pfizer, which included over 1,500 patients treated after coronary bypass graft (CABG) surgery. The study showed an increased cardiovascular risk in patients treated with Bextra compared to placebo. Heart attack, stroke and blood clots in the leg or lung were the adverse events that were observed.
The new "boxed" warning states that patients taking Bextra have reported potentially fatal skin reactions, including Stevens Johnson Syndrome and toxic epidermal necrolysis. Stevens Johnson Syndrome is a rare disorder characterized by inflammation of the mucous membranes of the mouth, throat, genital region, intestinal tract and membrane lining the eyelids. Toxic epidermal necrolysis is a skin disorder characterized by a blistering and peeling of the top layer of skin. In a few cases, these reactions have resulted in death.
These warnings come during a period where the overall safety of the COX-2 Inhibitors has been called into question after the worldwide withdrawal of Vioxx by Merck & Co.
Click here to read the FDA Talk Paper regarding the new warnings on Bextra.