FDA Recommends Limiting Use of Celebrex® and Bextra®
WASHINGTON, DC -- December 30, 2004 -- The arthritis drugs Celebrex® (celecoxib) and Bextra® (valdecoxib) may be linked to an increased risk of heart attacks and strokes, especially when they are used for long periods of time or after heart surgery, the Food and Drug Administration (FDA) warned in a recent public health advisory. The agency told doctors to weigh the benefits and risks of these drugs for individual patients. It also began a review of all prevention studies involving Celebrex® and Bextra®. A prevention study is one in which healthy people are given medicine to prevent a disease or condition.
The FDA action comes after the National Institutes of Health halted a prevention study of 2,000 patients at risk for developing colon growths or polyps. Those patients who took Celebrex® had a much greater chance of having heart attacks or strokes than did those who took fake pills or placebos. (See Celebrex® May Increase the Risk of Strokes). A study involving heart bypass patients and Bextra® revealed similar problems. Patients who took Bextra® after their surgeries were more likely to develop further heart complications compared with those who took placebos.
All NSAIDs Should Be Used With Caution
Bextra® and Celebrex® are used to treat the symptoms of rheumatoid arthritis and osteoarthritis, and to relieve painful menstrual cramps. They belong to a large class of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs), which includes more traditional drugs such as aspirin, naproxen (Aleve®), and ibuprofen (Motrin® and Advil®).
Bextra® and Celebrex® are in a newer subclass of NSAIDs called COX-2 inhibitors. Another COX-2 inhibitor, Vioxx®, was withdrawn from the market in September because it increased the risk of heart attacks, strokes, and blood clots.
The FDA suggests that all NSAIDs be used with caution, whether they are traditional medicines or COX-2 inhibitors. Doctors should consider the patient's risk for heart problems with every prescription written. Consumers should carefully follow the label directions on any over-the-counter NSAIDs, and discontinue their use after 10 days, unless told to do otherwise by their doctors.
The agency's advice about over-the-counter NSAIDs was influenced by a three-year prevention study involving Alzheimer's patients and the painkiller naproxen, which is sold either by prescription or directly to consumers as Aleve®. Patients who took naproxen had about twice the risk of having heart attacks or strokes compared to those who took placebos. (See Aleve® May Increase Heart Problems).
The FDA will continue to review studies about naproxen, Vioxx®, Celebrex®, Bextra®, and other NSAIDs. It will also hold an advisory committee meeting in February 2005 to help determine whether to take further action on these drugs.
Brayton Purcell is currently reviewing cases involving Celebrex® users who have suffered from heart attacks and strokes. If you or a loved one has had these conditions while taking Celebrex® or shortly after discontinuing the medication, please contact us to learn about your legal choices.