Celebrex has been linked to an increased risk of blood clots, heart attacks, and strokes. Celebrex is used to treat arthritis and is also a COX-2 inhibitor, marketed by Pharmacia Corporation and Pfizer Inc. in the United States . The drug is prescribed for the treatment of osteoarthritis, adult rheumatoid arthritis, and the pain associated with menstrual cramping.
Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the panel of FDA advisers.
A 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.
CELEBREX ® SIDE EFFECTS
- Heart Attack
- Birth Defects
- Pregnancy Complications
- High Blood Pressure
- Liver Damage
- Significant Bleeding
- Indigestion and Heartburn
- Upper Respiratory Tract Infection
- Sinus Inflammation
CELEBREX ® users suffering from any of the above symptoms should immediately contact a physician. The Food and Drug Administration advised all doctors to consider avoiding Celebrex.
The National Institutes of Health announced that they were going to suspend the use of Celebrex for all participants in a large colorectal cancer prevention clinic.
KEY DATES ON CELEBREX
- April 7, 2005, the FDA asked Pfizer, Inc. to withdraw Bextra from the market.
- December 20, 2004, the FDA mandated that Pfizer pull all Celebrex advertising from TV, radio, newspapers, and magazines.
- December 2004, the FDA announced a Public Health Advisory recommending the limited use of of Celebrex after studies showed that the use of Celebrex more than doubled the risk of heart attacks and strokes.
- December 20, 2004, The National Institutes of Health halted an Alzheimer’s prevention study of Celebrex.
- December 17, 2004, Pfizer announced that a study sponsored by the National Cancer Institute shows that Celebrex more than doubled the risk of heart attacks and strokes.
- June 8, 2002, the FDA said that CELEBREX ® must continue to carry a warning on the arthritis drug’s label that it can result in serious ulcer complications.
- 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.
- August 2001, the medical journal, JAMA (Journal of the American Medical Association), raised concerns over the possible impact on cardiovascular health.
- December 23, 1999, the FDA approved CELEBREX ® as a drug treatment aimed at reducing the number of intestinal polyps in patients with a rare genetic disorder called familial adenomatous polyposis (FAP).
- December 31, 1998, CELEBREX ® (Celecoxib) was approved by the US Food and Drug Administration for the treatment of rheumatoid arthritis and osteo-arthritis.