Case Against Bextra Tips
Read these 9 Case Against Bextra Tips tips to make your life smarter, better, faster and wiser. Each tip is approved by our Editors and created by expert writers so great we call them Gurus. LifeTips is the place to go when you need to know about Bextra tips and hundreds of other topics.
The Bextra debate
One criticism of Bextra and other COX-2 nonsteroidal anti-infalmmatory drugs is that they were sold with a one-size-fits-all dosage for osteoarthritis, unlike traditional NSAIDs that come in a variety of sizes and doses. So, in the words on one critic, "your 90-year old grandmother with arthritic hands will receive the very same, super-strong dosage as Shaquille O'Neal will receive for his arthritic toe."
Side effects of Bextra
Bextra safety concerns have been mounting ever since the recall of a similar drug. Vioxx is a prescription medication, similar to Bextra in form and function, which was recalled from the market in September 2004 after studies revealed that patients taking this pain killer for eighteen months were twice as likely to suffer from heart attack or stroke as the general population.
The Bextra debate
The American Heart Association's annual meeting convened in New Orleans in November, 2004. During this conference a leading heart researcher disclosed information about Bextra safety in terms of cardiovascular risks. This expert cited a recent study that indicated patients who take Bextra after cardiac bypass surgery are at an increased risk of suffering from cardiovascular complications, as compared to patients who had not taken Bextra after undergoing a similar surgical procedure.
Side effects of Bextra
Bextra warning statements have been included in packaging since 2002. The FDA is considering adding a Bextra warning black box to all Bextra labeling, which is the FDA's strongest alert of drug dangers. The legitimacy of Bextra warning statements regarding cardiovascular health is suggestive, but still inconclusive. If you are concerned about Bextra warning information, you should speak with your doctor. If you have suffered adverse health problems as a result of taking Bextra, you may wish to consult a lawyer about your rights and options in a civil case to recover damages.
The Bextra debate
Pfizer has taken limited steps to warn the public about the dangerous side effects from Bextra use, and unfortunately only pulled the drug off the market after the FDA asked for a voluntary removal. Information about the dangers of Bextra are now widely available. The Food and Drug Administration is an excellent source of information, as are several medical consumer advocacy groups.
The Bextra debate
More than 10 million people were using a COX-2 anti-inflammatory drug on Sept. 30, 2004, when Merck announced Vioxx's withdrawal, followed by a suspension of sales of Bextra by Pfizer. In 2003, Vioxx, Celebrex, and Bextra reaped more than $6 billion in sales, driven by $400 million in advertising targeting doctors and consumers. These sales were driven by claims that COX-2 anti-inflammatory drugs were safer than older NSAIDs such as Motrin, Voltaren, and Naprosyn; claims that have still not convinced many experts, especially in light of recent new studies.
What is the consensus of the medical community regarding Bextra?
Studies suggesting possible dangerous side effects of COX-2 inhibitors such as Bextra remain inconclusive and even contradictory. However, there is enough evidence that the FDA has made the following interim recommendations: Physicians prescribing Celebrex or Bextra , should consider this information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal bleeding, have a history of intolerance to non-selective nonsteroidal anti-inflammatory drugs (NSAIDs), or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents. Risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account on an individual basis.
Bextra and the FDA
FDA announced in December of 2004 that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents such as Bextra to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition. The FDA issued the advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings, such as immediately after heart surgery.
Bextra and the FDA
Concern about Bextra stroke and heart attack risks first came to the fore of social concern after a similar drug was recalled because of its cardiovascular risks. Vioxx, also a COX-2 selective non-steroidal anti-inflammatory drug, was voluntarily pulled from the shelves by its maker in September 2004.
