Drugs & Medical Devices

CELEBREX

Celebrex is a COX-2 non-steroidal anti-inflammatory (NSAID), developed by G. D. Searle & Co. and approved by the FDA for treatment of rheumatoid arthritis and osteoarthritis in December of 1998. Since introduction into the U. S. market, sales of Celebrex reached $1 billion dollars within its first year of marketing. Celebrex is co-marketed by Pharmacia, the corporation which owns Searle and Pfizer, Inc.

Celebrex has been referred to as the "super aspirin". It contains a sulfonamide derivative which is well-known to cause Stevens-Johnson syndrome. There have been reported cases of Stevens-Johnson Syndrome associated with the use of Celebrex, as well as other serious skin reactions. Pharmacia maintained that Celebrex was safer and gentler on the stomach compared to older NSAIDS.

COX-2 INHIBITORS

Vioxx and Celebrex are classified as and known as COX-2 inhibitors, or coxibs. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDS. Older NSAIDS reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking COX-2 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone.

A class study performed on Celebrex was unable to conclude that Celebrex established a safety advantage over older NSAIDS. The class study also failed to show that Celebrex worked any more safely than NSAIDs regarding ulcer complications. Both Celebrex and Vioxx manufacturers made continuous attempts to have label warnings removed in order to gain the upper hand on one another. The tight competition between the two companies was highly criticized for sacrificing patient safety.

On April 6, 2000, after several warnings to Pharmacia that their promotional advertisements were misrepresenting the safety of Celebrex, the FDA issued a letter to the drug company demanding changes to their label. The letter states "your representatives continue to engage in violative promotional practices."

An article published in August, 2001 in the medical journal, JAMA (Journal of the American Medical Association), raised concerns over the possible impact on cardiovascular health. In September of 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Celebrex's manufacturer, Pharmacia Corporation, to test whether Celebrex increases the risk of heart attack and stroke.

The FDA recently issued a new labeling mandate for Celebrex after they determined that it was no less likely to promote ulcers than Ibuprofen or Diclofenac. The FDA further determined that Celebrex was no more effective than older medications on the market. The new labeling is likely to make managed-care companies less likely to cover Celebrex for patients.

The popular and heavily advertised arthritis drugs Vioxx and Celebrex have been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes. The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials.

In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib (Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack, chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.

The annual rates of heart attack in both the Celebrex (celecoxib) and Vioxx (rofecoxib) studies were increased compared to a review of studies containing a total of more than 48,000 patients. In those studies, 0.52% of patients taking an inactive placebo pill had a heart attack each year. The annual rate of heart attack was 0.74% for patients taking rofecoxib and 0.80% for those taking celecoxib.

If you or a loved one have taken Celebrex for 18 months, and subsequently suffered a heart attack, stroke, or serious clot, contact Davis & Feder P.A. at 1-866-857-8500 for a free, initial consultation. We review cases anywhere in the country. An experienced attorney will assist you in evaluating your claim.

VIOXX/CELEBREX/BEXTRA LINKS:

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product.

Bextra Effects on Heart Patients

Side effects of Vioxx.

The double edge sword of COX-2 NSAIDS.

Bextra information provided by FDA.

Consumer information regarding Celebrex.

Briefing Document for the FDA Advisory Committee prior to withdrawal of Vioxx.