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Celebrex® Label Insert May Include New Warning

Arthritis Drug Bextra® Withdrawn from the Market

WASHINGTON, D.C. -- April 13, 2005 -- The drug manufacturer, Pfizer, has withdrawn Bextra® (valdecoxib), from the market at the request of the Food and Drug Administration (FDA). Bextra® is used to relieve the symptoms of osteoarthritis and rheumatoid arthritis. However, the drug may increase the risk of heart attacks and strokes, especially among patients who have undergone coronary bypass surgery.

Bextra® contains sulfa, a substance linked to skin allergies. The drug can cause Stevens-Johnson syndrome, a painful blistering of the skin and mucous membranes that sometimes proves fatal. According to the FDA, the skin allergy risk from Bextra® "is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use" (FDA Health Advisory, April 7, 2005).

All COX-2 Inhibitors, Including Celebrex®, are Suspect

Bextra® is a nonsteroidal anti-inflammatory drug (NSAID) that blocks cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins can cause inflammation and pain. Bextra® interferes with the form of cyclooxygenase known as COX-2, and is therefore among the class of painkillers known as COX-2 inhibitors.

Another COX-2 inhibitor and arthritis drug, Vioxx®, was withdrawn from the market in September of last year because it increased the risks of heart attacks and strokes. The FDA is now asking Pfizer to include a "black box warning" about the risk of heart problems in the package insert for Celebrex®, the remaining prescription COX-2 arthritis drug still available in the United States.

A black box warning is the most serious FDA alert about a drug's side effects. The Celebrex® black box would:

  • Summarize Celebrex® studies and clinical trials that show the medication's link to heart problems
  • Describe the increased risk of heart problems from Celebrex® and the "serious, and potentially life-threatening" stomach and intestinal bleeding associated with its use.
  • Encourage doctors to discuss the benefits and risks of Celebrex® and other treatment options with their patients.

The FDA asks doctors to use the lowest effective Celebrex® dose for the shortest length of time. It will require Pfizer to conduct a long-term study comparing the safety of Celebrex® with naproxen, a more traditional NSAID, and with other related drugs. In addition, patients should receive Medication Guides describing the problems associated with Celebrex® use.

The agency also requests that manufacturers of prescription NSAIDs such as prescription-strength naproxen and ibuprofen include black box warnings in label inserts. The warnings would discuss the risk of heart problems and state that the medications are not suitable for patients who have undergone coronary artery bypass surgery.

Although black box warnings are not required for over-the-counter NSAIDs, the FDA asks that their labels be revised to provide alerts about possible heart problems. These products include nonprescription ibuprofen (Motrin®, Advil®, Ibu-Tab 200®, Medipren®, Cap-Profen®, Tab-Profen®, Profen®, Ibuprohm®), naproxen (Aleve®), and ketoprofen (Orudis®, Actron®). The list does not include common aspirin.

Evaluating Your COX-2 Case

Brayton Purcell is evaluating cases of heart attacks, strokes, and blood clots that are linked to COX-2 arthritis drugs. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please feel free to contact us.

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