Celebrex Gets Black Box Warning

August 2005

Celebrex users, beware. The controversial pain reliever, the only Cox-2 inhibitor still available in the U.S, is getting a Food & Drug Administration (FDA) “black box” warning.

The new “black box” label, the strongest warning available for drugs, cautions users about the increased risk of heart attacks and strokes. The “black box” warning is similar to warning labels that will be added to older pain relief medications such as ibuprofen and naproxen.

Celebrex’s label recommends that the drug be prescribed at a low dosage and only for a short time. The FDA approved Celebrex for the treatment of severe pain attributed to osteoarthritis and rheumatoid arthritis and adenomatous polyposis, a rare condition that causes colon cancer.

Previously, Cox-2 inhibitors drugs Bextra and Vioxx were both taken off of the market after studies proved the drugs increased the risk of heart attacks and strokes. Read more on Celebrex.