Consumer Group Calls New Celebrex® Ad Misleading, Asks FDA to Intervene
WASHINGTON, DC -- April 13, 2007 -- An advertisement about the arthritis drug Celebrex® is misleading and should be withdrawn, according to the consumer group, Public Citizen. The organization sent a letter to the Food and Drug Administration (FDA) charging that the two-and-a-half minute TV spot downplayed Celebrex®'s poor safety profile (Public Citizen, April 9, 2007).
The ad wrongly implies that any heart problems caused by Celebrex® are not greater than those caused by certain other painkillers such as naproxen, the consumer group said. It also objects to language that suggests that Celebrex® users have less bleeding and stomach problems than do patients who take ibuprofen or naproxen.
"The ad violates FDA law and regulations because it contains several false or misleading statements that will lead many viewers to underestimate the cardiovascular and gastrointestinal risks of Celebrex® and use it in preference to equally effective, safer alternatives such as OTC [over-the-counter] naproxen," the letter concludes.
Celebrex® Side Effects and the COX-2 Drugs
Common aspirin, ibuprofen, and naproxen are in the family of medications known as nonsteroidal anti-inflammatory drugs or NSAIDs. NSAIDs block cyclooxygenase, an enzyme involved in inflammation.
Traditional NSAIDs block two forms of cyclooxygenase, COX-1 and COX-2. Newer NSAIDs, including the painkillers Vioxx®, Bextra® and Celebrex®, only block the COX-2 enzyme and are therefore known as COX-2 inhibitors
Celebrex® is closely related to Vioxx® and Bextra®, which were pulled from the market because they increased the risk of heart attacks and strokes.
Public Citizen points to a 2006 study that showed the link between cardiovascular problems and COX-2 drugs, including Celebrex® (BMJ. 2006 Jun 3; 332(7553): 1302-8). The study found no such effect for the more traditional NSAID, naproxen. The letter also notes: "Considering all studies about gastrointestinal risk, there is no evidence of a net gastrointestinal benefit for Celebrex® compared to other NSAIDS."
Celebrex® "Black Box" Warnings
- Celebrex® may increase the risk of blood clots, myocardial infarction (heart attack), and stroke, which can be fatal.
- The drug should not be used to treat pain following coronary artery bypass surgery.
- Celebrex® use may increase the risk of stomach bleeding and ulcers, especially among elderly patients. These events may occur without warning, and can be life threatening.
Your Celebrex® Case
Brayton Purcell believes that Celebrex® is not a safe drug and that its risks outweigh its benefits. Please feel free to contact us if you have used Celebrex® and had a heart attack or stroke. We will answer your questions, review your case free of charge and advise you of your legal options.