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Mass Tort Update
Celebrex, the brand name of the generic drug celecoxib, was approved by the U.S. Food and Drug Administration (FDA) on December 31, 1998, for the treatment of rheumatoid arthritis and osteoarthritis 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), an inherited disorder that, if left untreated, always develops into colon cancer. Celebrex is a non-steroidal anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as "Cox-2 inhibitors."
Although steroids are considered safe for brief use to reduce inflammation, when taken for longer periods, they can cause serious side effects like weight gain, fluid retention often visible in the face, sudden mood swings, muscle weakness, blurry vision, increased body hair, osteoporosis (bone weakening), high blood pressure, stomach irritation, and/or glaucoma. Consequently, NSAIDs are preferred for the reduction of inflammation if steroids can be avoided.
Celebrex works by preventing the formation of "inflammatory" prostaglandins. These compounds are produced by the enzyme "cyclooxygenase 2," commonly referred to as "Cox-2," and are believed to cause pain and inflammation, as well as prevent blood cells from sticking together. Unlike other NSAIDs, Celebrex does not also block a second enzyme, commonly called "Cox-1," which monitors and maintains stomach tissue. Since this enzyme protects the stomach lining, Celebrex has been promoted as being able to reduce pain and inflammation without also causing ulcers and gastrointestinal bleeding.
This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Celebrex. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Celebrex. Older adults may have an even greater risk of these serious gastrointestinal side effects.
An article published in the August 2001 Journal of the American Medical Association (JAMA) raised concerns over Celebrex's possible impact on cardiovascular health, implicating Celebrex in heart attacks and other heart irregularities. Although doctors rushed to write rebuttal letters, in September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Pharmacia (later bought by Pfizer) to test whether Celebrex increased the risk of heart attacks and strokes. Pharmacia disputed the findings reported in JAMA and insisted Celebrex is safe.
On December 17th, 2004 the National Institutes of Health (NIH) announced that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo.
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