Bextra® Label Updated to Warn About Heart Problems and Stevens-Johnson Syndrome
WASHINGTON, DC -- December 17, 2004 -- Patients who have undergone heart bypass surgery should not take the popular arthritis drug, Bextra®, because it increases their risk of additional heart problems, according to a warning added to the drug's label by the Food and Drug Administration (FDA). Highlighted in bold letters, the new language also states that Bextra® increases the likelihood of wound infections in these patients.
Pfizer, the manufacturer of Bextra®, recently reported on a study of over 1,500 heart bypass surgery patients. Those who took Bextra® for pain relief had a greater chance of having heart attacks, strokes, and blood clots than did patients who took placebos. The results were similar for another study published last year involving 462 patients who had heart bypass operations at hospitals in the United States, Canada, Germany, and the United Kingdom (J Thorac Cardiovasc Surg. 2003 Jun; 125(6): 1481-92).
Bextra® and Vioxx® Increase Heart Attack Risks
Also known as valdecoxib, Bextra® is used to relieve the symptoms of osteoarthritis and rheumatoid arthritis, and to treat painful menstrual periods (dysmenorrhea). A related arthritis drug, Vioxx® (rofecoxib), was withdrawn from the market in September because it was linked to heart attacks and strokes.
Both Bextra® and Vioxx® are nonsteroidal anti-inflammatory drugs (NSAIDs) that block cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Bextra® and Vioxx® interfere with the form of cyclooxygenase known as COX-2, and are therefore referred to as COX-2 inhibitors.
Some experts believe that all COX-2 inhibitors may cause heart ailments. The FDA will meet in February, 2005, to consider the safety record of these drugs, and how the agency can improve its efforts to protect the public.
Bextra® Can Cause Severe Skin Reactions
Medical experts are also concerned about Bextra® because the drug can cause a severe allergic skin reaction known as Stevens-Johnson syndrome in some users. Considered a disorder of the immune system, Stevens-Johnson syndrome leads to a painful blistering of the skin and mucous membranes. The patient's skin may slough off; eyesight may also be affected. In some cases, Stevens-Johnson syndrome can prove fatal.
The FDA has added a prominent "black box" to the Bextra® label informing doctors that the drug may cause Stevens-Johnson syndrome. This type of alert is considered the strongest warning for a drug that is still on the market. Although skin reactions are most likely to occur in the first two weeks after treatment with Bextra®, the FDA notes that they can occur any time during therapy. It advises doctors to have their patients stop taking Bextra® at the first signs of skin rashes or mouth sores. The boxed warning also states that Bextra® contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk for adverse skin reactions.
For further details about the side effects of Bextra®, see the new product label and the FDA's Questions and Answers About Bextra®. Brayton Purcell is currently evaluating claims of Bextra® users who have suffered from heart attacks, strokes, vascular disease, or severe skin problems. If you or a loved one has taken Bextra® and experienced these problems, please feel free to contact us to learn about your legal choices.