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Celebrex® is Related to Vioxx®, Which Was Recalled

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Celebrex® Heart Attack Risks Outweigh Drug’s Potential for Preventing Colon Cancer

BOSTON, MA — September 8, 2006 — Although the arthritis drug Celebrex® (celecoxib) may prevent the occurrence of colon polyps, the drug increases the risk of heart attacks, according to two studies. Colon polyps or adenomas are noncancerous growths on the wall of the colon that may later develop into cancer. Surgeons perform an operation called a colonoscopy to detect and remove adenomas before they can cause harm.

About 1500 patients had adenomas removed during surgeries prior to the start of one study (the Prevention of Colorectal Sporadic Adenomatous Polyps trial or PreSAP; N Engl J Med. 2006 Aug 31; 355(9): 885–95). During the clinical trial, two thirds of the group received 400 milligrams of Celebrex® per day; the others took placebos or fake pills. After one year, 49% of patients who did not take Celebrex® developed polyps, but only 33% of patients receiving Celebrex® developed polyps. At three years, the percent of non–Celebrex® users who developed new polyps (10.4%) was almost twice the percentage for Celebrex® users (5.3%). Despite these good results concerning polyps, 2.5% of the patients taking Celebrex® had heart attacks or strokes compared with a rate of 1.9% in the group who did not take the drug.

In another Celebrex® study, over 2000 patients were divided equally into three groups (the Adenoma Prevention with Celecoxib or APC study; N Engl J Med. 2006 Aug 31; 355(9): 873–84). Patients in each group received either 400 milligrams of Celebrex® daily, 800 milligrams daily, or a placebo. All patients had had adenomas removed before the study began. Once again, patients who did not take Celebrex® had a greater risk of developing polyps than did those who took the drug. However, in this case, the increase in heart attacks and strokes among Celebrex® users was much more pronounced than in the other study, especially among the patients taking 800 milligrams of Celebrex® per day.

Two researchers analyzed both Celebrex® studies, concluding that the risk of heart attacks and strokes increased by a factor of about two for Celebrex® users compared with those who took placebos (N Engl J Med. 2006 Aug 31;355(9): 950–2 fee required for access to full article). They also pointed out that aspirin may actually decrease heart attack risk, and is only slightly less effective in reducing adenoma risk than Celebrex® is.

Weighing the risks and benefits of aspirin and Celebrex® as well as the frequency of heart problems and adenomas, the researchers concluded that Celebrex® has no role as a chemopreventive agent. They suggested that patients who are at risk for developing colon cancer have regular check–ups and colonoscopies and take low–dose aspirin.

How Celebrex® Works

Celebrex® (celecoxib) and aspirin are both in the category of drugs known as NSAIDs (nonsteroidal anti–inflammatory drugs), which are used to reduce pain and inflammation. Celebrex® is a newer “COX–2” medication. COX–2 medicines are so named because they block cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins cause inflammation.

Two COX–2 inhibitors, Bextra® and Vioxx®, were recalled because they increase the risk of heart attacks, strokes, and blood clots. Like Celebrex®, both drugs were used to treat arthritis pain.

Your Celebrex® Case

Brayton Purcell is currently reviewing cases involving patients who took painkillers and suffered from heart attacks and strokes. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please contact us to learn about your legal choices.

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