Celebrex® Gets "Black Box" Warning
WASHINGTON, DC -- August 22, 2005 -- The Food and Drug Administration (FDA) has ordered Pfizer to upgrade the label warnings for Celebrex® (celecoxib) to state that the arthritis drug may increase the risk of heart attacks, strokes, and blood clots. Doctors are also advised that the drug should not be used following coronary bypass surgery, and that it may cause stomach bleeding and ulcers.
The warnings must be contained in a "black box" on the prescribing instructions. A black box note is the highest alert that can be placed on a drug short of taking it off the market. An FDA panel had recommended the black box warning in February of this year. The agency also issued a health advisory last year about the link between Celebrex® and heart problems.
The FDA was responding to the results of a clinical trial in which 2,000 patients with recurring colon polyps took either Celebrex® or fake pills (placebos). Compared to patients who took placebos, the Celebrex® group had an increased risk of heart attacks and strokes. The risk increased as the Celebrex® dose increased. Due to safety issues, the study, known as the Adenoma Prevention with Celecoxib or APC trial, was halted before it could be completed (National Health Institute Press Release, December 17, 2004).
How Celebrex® Works
Celebrex® (celecoxib) is used to relieve the symptoms of osteoarthritis and rheumatoid arthritis. The FDA has also approved the drug to treat acute pain, cramps from severe menstrual periods, and the symptoms of ankylosing spondylitis, a form of arthritis that affects the spine.
Celebrex® is in the family of drugs known as COX-2 inhibitors. These medications are nonsteroidal anti-inflammatory drugs (NSAIDs) that block cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins cause inflammation and pain.
Two COX-2 inhibitors, Bextra® and Vioxx®, were recalled because they increase the risk of heart attacks, strokes, and blood clots. In addition, some people also develop a severe skin allergy known as Stevens-Johnson syndrome if they take Bextra®. Both drugs were used to treat arthritis pain.
Celebrex® and Your Legal Case
Brayton Purcell is currently reviewing cases involving patients who took painkillers and suffered from heart attacks, blood clots, 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.