"Class Effect": Like Bextra and Vioxx, Celebrex Can Cause Heart Attacks and Strokes

The pharmaceutical company Pfizer Inc. announced on August 1, 2005 that the FDA had finalized a new label for the arthritis drug Celebrex, which will include a "black box" warning informing doctors and patients about the associated increased cardiovascular risks, such as heart attacks and strokes.

The black box warning which to be added to Celebrex is similar to the black box warnings that will be added to older painkillers such as ibuprofen and naproxen in the near future. These package insert label changes are consistent with the February 2005 recommendations of an outside panel of medical experts which the FDA convened in February 2005 to address emerging concerns about whether Celebrex increased cardiovascular risks like Vioxx and Bextra, other drugs in the same COX-2 class as Celebrex; the panel agreed that there was a "class effect" at work.  The expert panel also studied the safety profile of the older painkillers.

Celebrex’s revised label will include the recommendation to doctors that Celebrex be prescribed at the lowest dose and for the shortest duration possible. In addition, this new Celebrex label will carry a warning that Celebrex should not be used to treat pain associated with heart-bypass surgery.

Celebrex had been approved to treat pain associated with osteoarthritis as well as rheumatoid arthritis, and as a treatment for familial adenomatous polyposis — a rare condition that leads to colon cancer.  Coincidental with the Celebrex label change, Pfizer announced that the FDA has recently approved Celebrex as a treatment for ankylosing spondylitis, a form of arthritis which affects the spine.

(Posted by: Tom Lamb)