12-17-04

Pfizer Inc.  reported that it has found an increased risk of heart attacks for patients taking high dosages of its top-selling painkiller Celebrex, the same problem that led to the withdrawal of its one-time competitor Vioxx.  The news sent the stock of the giant pharmaceutical maker plunging in early December 17, 2004 trading on the New York Stock Exchange.

The withdrawal of the popular arthritis drug Vioxx from the worldwide market had fueled concerns about the drug Celebrex. Celebrex, like Vioxx, is a medication called a COX-2 inhibitor. COX-2 inhibitors have been linked to an increase in the risk of blood clots, heart attacks and strokes.

Researchers have stated that since Pfizer Inc.’s Celebrex, often called a “super aspirin,” is in the same class of drugs as Merck & Co.’s Vioxx, it likely carries the same risks. Studies have shown that drugs such as Celebrex and Vioxx that treat pain by inhibiting an enzyme known as COX-2 may also cause heart problems. In a letter to the New England Journal of Medicine, Garret A. FitzGerald, chairman of the department of pharmacology at the University of Pennsylvania in Philadelphia, stated that there is evidence that the cardiovascular risks may stem from a mechanism common to all COX-2 inhibitors.

Pfizer denies that its drug is also linked to heart risks. Celebrex (Celecoxib) was approved by the FDA in December 1998 for the treatment of rheumatoid arthritis and osteoarthritis. A year later, the FDA approved it as a drug treatment aimed at reducing the number of intestinal polyps in patients with a rare genetic disorder called familial adenomatous polyposis (FAP). Pfizer acquired Celebrex and Bextra when it bought Pharmacia Corp. in April 2003. Bextra is the company’s newer painkiller and is in the same category of medications. Learn more about the dangers of Bextra.

Health concerns about the use of Celebrex have been raised in the past. In the August 2001 edition of the medical journal JAMA (Journal of the American Medical Association), an article raised concerns about the drug’s impact on cardiovascular health. The next month, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Celebrex's manufacturer to test whether Celebrex increases the risk of heart attack and stroke.

The FDA sent Pharmacia Corp. a “warning letter” about the company’s promotional campaign for Celebrex, as it did with Vioxx. The letter was sent for the same reasons the FDA had warned Merck & Co, the maker of Vioxx – the campaign minimized the potentially serious cardiovascular findings that were observed in trials. The FDA charged that Pharmacia Corp. had discounted the fact that patients on Celebrex were observed to have a four to five-fold increase in heart attacks, compared with patients on other painkillers.

In addition to increased risk of heart attack and stroke, patients taking Celebrex are also at heightened risk of gastrointestinal hemorrhage, ulcers and kidney problems. Other possible side effects:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives)
• abdominal pain, tenderness, or discomfort
• bloody, black, or tarry stools
• nausea or heartburn
• bloody vomit
• unexplained weight gain
• swelling or water retention
• unusual fatigue or lethargy
• a skin rash or itching
• yellowing of your skin or eyes
• “flu-like" symptoms
• unusual bruising or bleeding

If you are experiencing any of the above listed side effects, and have taken Celebrex, contact Belluck & Fox immediately for a legal evaluation. Drug litigation can be extremely complex. It is best to seek the counsel of a personal injury attorney with experience in this field of law. Belluck & Fox has substantial experience with defective product litigation, including Celebrex pharmaceutical and medical product cases.

Belluck & Fox, LLP, is located in the heart of New York City, on Madison Avenue. Call our Celebrex Lawyers today, toll free, at 1-877-NYLAW09 or contact us via our online form.

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