Submit your Defective Drugs claim details for a free, no obligation case review.
Get Started:
drug_recall bextraBextra was FDA approved on November 16, 2001 to treat primary dysmenorrheal, osteoarthritis and adult rheumatoid arthritis. Initially, the company also tried to get Bextra approval for treatment of acute pain but it was disapproved. After big Cox-2 inhibitors Vioxx and Celebrex were released in the late 1990s, followed by Bextra and other competing drugs, researchers were excited at what the new drugs could do. Discovering there were two types of cyclooxygenases, Cox-1 and Cox-2, which makes the natural chemicals prostaglandins that were the root cause of pain and inflammation, researchers realized there were "good" and "bad" prostaglandins that either protected the stomach or further caused inflammation.
The entrance of Cox-2 inhibitors like Bextra claimed the number of Bextra side effects suffered was less than the traditional ibuprofen medications. The initial excitement over Cox-2 drugs was the ability to block just the "bad" Cox-2 prostaglandins and leave the good prostaglandins present, claiming the same pain-free result as traditional medications. The Bextra side effects, on the other hand, were reduced, with the stomach effects associated to previous medications, such as bleeding ulcers eliminated.
Quickly gaining popularity, patients sought Cox-2 drugs for not just arthritis but for indications like migraines, acute pain, menstrual cramps and other symptoms, the minimal Bextra side effects being the main draw. It was not long until the highly popular drugs were delivered its first hit. Experts soon began to say that the Bextra side effects were not as obsolete as patients were led to believe and that Cox-2 inhibitors just reduce gastrointestinal side effects, they don''t eliminate them completely.
A study on the Cox-2 drug Celebrex in September 2000 involved 8,000 patients and showed people using the Cox-2 drug had fewer ulcer complications than those taking over-the-counter medications. While the Bextra side effects, as well as other Cox-2 drugs still appeared to be fewer, another analysis showed otherwise. The Celebrex study had focused on just six months of drug use, but when the FDA looked at 12 months of data, any type of advantage appeared to diminish completely.
An August 2004 study also showed combining a Cox-2 with a low dose of aspirin causes any reduced Bextra side effects to be lost completely. The study performed by Novartis is the largest Cox-2 study ever done. While the benefit of using a Cox-2 has been questioned, especially since they were specifically designed to have a much lower ulcer risk, the study exposed even more concerning news than gastrointestinal effects. Evidence indicates that Bextra side effects may also include increased risk of heart disease. Experts do caution more study is needed before the debate can properly be extinguished.
Bextra side effects were initially marketed to be minimal, creating a natural lure for patients wishing to seek a pain reliever. There were great hopes for the benefits Cox-2 inhibitors could provide and to eliminate problems, but as more evidence shows, this is not the case. More studies to determine more specific groups and the Bextra side effects present among them is needed as well, including patients at high risk or heart disease and digestive system complications.
Bextra , the popular cox-2 inhibitor recalled by Pfizer, is the subject of another lawsuit.
Rita Fohne has filed her lawsuit against Pfizer in Madison County, Illinois, seeking ...
The U.S. Food and Drug Administration has started issuing alerts to patients and doctors on its new site Drug Watch. Including emerging drug-safety concerns, as well as dangers presented by drugs prescribed for unapproved uses, the new site is in resp...
After a controversial year of drug recalls, the FDA was under attack for failing to adequately protect consumers from dangerous drugs. Currently, the FDA has the Adverse Event Reporting System, or AERS, to collect voluntary reports of possible reactio...