On Dec-17-04 Pfizer revealed that one of two clinical trials showed an increased cardiovascular risk for patients taking the arthrtitis medication Celebrex. Pfizer is taking steps to discover why there is a discrepancy between the two trials, but is not removing Celebrex from the marketplace. Doctors, however are becoming worried about possible heart attack and stroke for patients using Cox-2 inhibitor drugs, and are advising patients with heart disease not to use drugs such as Celebrex.

Vioxx, another Cox-2 inhibitor, was withdrawn from the marketplace in September 2004 when a link to serious heart problems was found in Vioxx users.

Celebrex (Celecoxib) was approved by the US Food and Drug Administration (FDA) on December 31, 1998 for the treatment of rheumatoid arthritis and osteo-arthritis, and on December 23, 1999 as a drug treatment aimed at reducing the number of intestinal polyps in patients with a rare genetic disorder called familial adenomatous polyposis (FAP). Celebrex is a non-steroidal anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as a “Cox-2 inhibitor.”

In September, 2001 the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Celebrex’ manufacturer (Pharmacia Corp.) to test whether Celebrex increases the risk of heart attack and stroke.

The US Food and Drug Administration sent Celebrex’ manufacturer (Pharmacia Corp.) a “Warning Letter” on February 1, 2001. The warning letter required Pharmacia Corp. to cease certain promotional activities for Celebrex.

Celebrex In the News
New Warnings Added to Celebrex; FDA Approves New Use
[MARKET WATCH]

The Intensive Medicines Monitoring Programme of New Zealand has published important safety data on patients taking COX-2 inhibitors. According to a new study, patients taking the arthritis drug Celebrex have a similar risk of heart attacks and stroke as those taking the withdrawn drug Vioxx.
[SCOOP INDEPENDENT NEWS]

The U.S. FDA has asked manufacturers of all marketed prescription Non-Steroidal Anti-Inflammatory Drugs, including Celebrex, to include a boxed warning. The revised labels will highlight the increased risk of cardiovascular events and the potential life threatening gastrointestinal bleeding associated with their use.
[U.S. FOOD AND DRUG ADMINISTRATION]