Celebrex is a prescription medication in a class of drugs called COX-2 non-steroidal anti-inflammatory drugs (NSAIDs). It is in the same class as Bextra and Vioxx. Celebrex is developed and manufactured by Pfizer, Inc., a global pharmaceutical company that manufactures many well known and widely used prescription and over the counter medications, including household names such as Listerine, Neosporin, Sudafed, Visine, Viagra and others.

Celebrex was originally approved in December 1998 to treat the pain of osteoarthritis and rheumatoid arthritis. It is also used to treat the symptoms of severe menstrual pain in some women, as well as ankylosing spondylitis (a painful, progressive, rheumatic disease that mainly affects the spine but can also affect other joints, tendons and ligaments). Additionally, Celebrex may be used to treat acute pain and has been associated with the reduction of colorectal polyps.

While NSAIDs are very effective at treating the painful symptoms of the aforementioned illnesses, the use of COX-2 drugs, including Celebrex, is associated in some patients with serious problems from stomach ulcers, including internal bleeding, and with liver damage. Perhaps more importantly, Celebrex and other drugs in its class have been closely linked with an increase in cardiovascular events, including heart attack, blood clots and stroke.

Controversy over this class of drug started with the voluntary recall of Vioxx by its manufacturer in September 2004, after it was determined that the drug almost doubled the risk of some cardiovascular events in certain patients. This led the FDA and others to take a closer look at the possible adverse side effects of the entire class of drugs. The side effects include:

• Fainting.
• Kidney and heart failure.
• Aggravation of hypertension.
• Chest pain.
• Ringing in the ears.
• Deafness.
• Stomach and intestinal ulcers.
• Bleeding.
• Blurred vision.
• Anxiety.
• Photosensitivity.
• Weight gain.
• Water retention.
• Flu-like symptoms.
• Drowsiness.
• Weakness.

Initially, Celebrex was considered a gentler product than traditional NSAIDs, including aspirin and ibuprofen. This is because all NSAIDs inhibit COX-2, an enzyme linked to pain and inflammation, but Celebrex is one of the only ones that does not inhibit COX-1, which is thought to help keep the stomach lining intact. While this evidence leads to the conclusion that Celebrex is kinder to the digestive tract than other NSAIDs, the FDA has not yet allowed manufacturer to formally make that claim.

In December 2004, the FDA released a statement addressing a clinical trial being conducted by the National Cancer Institute involving the use of Celebrex to prevent colon polyps. The trial was halted and the FDA became involved because of an increased risk of cardiovascular (CV) events in patients taking Celebrex versus those taking a placebo. Patients in the clinical trial taking 400 mg of Celebrex twice daily had a 3.4 times greater risk of CV events compared to those taking placebo. For patients taking 200 mg of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

Due to the alarming side effects caused by Celebrex and other COX-2 inhibitors, an FDA advisory panel comprised of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Managements Advisory Committee, met for three days to discuss the class of drugs and came to a number of conclusions.

The committee strongly recommended that the FDA require a "black box" warning for the COX-2 inhibitors currently on the market. A black box warning is the strongest warning the FDA can make. Additionally, while the panel concluded that Celebrex and other COX-2 inhibitors carry serious risks of heart attack and stroke, due to the challenge of making decisions in the face of imperfect science and inconclusive evidence, the committee did not recommend that Celebrex and others be removed from the market.

On July 29, 2005, Pfizer Inc. added a black box warning to the Celebrex label. The new black box warnings include:

• Increased risk of cardiovascular (CV) thrombotic events, including myocardial infarction and stroke.
• Contraindication for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Increased risk of gastrointestinal events such as bleeding, ulceration, and perforation of the stomach or intestines
.

Currently, Pfizer's Celebrex (celecoxib) is the only Cox-2 inhibitor NSAID to survive the recent FDA scrutiny and to remain on the market. However, the potential side effects and other serious health concerns still exist.