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Prescription Medications :Bextra (Valdecoxib)
Bextra (Valdecoxib) was the third approved (November 2001 U.S. FDA) COX-2 inhibitor nonsteroidal anti-inflammatory drug (NSAID). NSAID's work mainly by preventing the formation of prostaglandins, hormone-like substances which trigger pain and inflammation. Prostaglandins are produced within the body's cells by the enzyme cyclooxygenase (COX).
In 1989 scientists discovered that there are two varieties of the Cox enzyme - which came to be known as COX-1 and COX-2. COX-1 is continuously secreted within the stomach and duodenum, and is important for maintaining a healthy stomach lining, normal kidney function and the clotting action of blood platelets.
In contrast, the COX-2 enzyme is primarily found at sites of inflammation. The conventional, first generation NSAID's (aspirin, diclofenac, ibuprofen etc.) work by inhibiting both COX-1 and COX-2 enzymes. By blocking COX-2 they are effective in relieving pain and inflammation, but by inhibiting COX-1 they produce a much greater likelihood of gastrointestinal (GI) side effects including diarrhea, heartburn and ulcers. In 1998, with the U.S. FDA approval of Celebrex (Celecoxib), a new type of NSAID came onto the market, called the "selective COX-2 inhibitor" (also known as "coxib"). Followed by Vioxx (Rofecoxib) in 1999 and Bextra (Valdecoxib) in 2001, the COX-2 inhibitors are believed to vary in their COX-2ýselectivity. Mobic (Meloxicam) has some COX-2 selectivity (estimated at 18 times) and is referred to as a "preferential COX-2 inhibitor".
In general, the COX-2 meds have been shown to provide comparable pain relief and to cause significantly fewer adverse gastrointestinal (GI) events than the conventional, nonselective NSAID's. However, from early in the development process, concerns began to be raised about potential negative effects of this new class of drugs on the heart. Perhaps the first indication that there might be some cardiovascular impacts surfaced from the VIGOR study in which more than 8,000 Rheumatoid Arthritis patients were randomly assigned to receive either Vioxx 50 mg a day (twice the highest approved dose for chronic use) or a standard dose of a standard NSAID, Naproxen (1000 mg a day).
The VIGOR study found that those taking the Vioxx had a three time greater risk of suffering from a heart attack or stroke compared to those taking Naproxen. In 2004, Cardiovascular Events Associated with Rofecoxib, found that that the risk of developing a heart attack and/or stroke was almost double in patients who received Vioxx compared to patients who took a placebo. On September 30, 2004, citing this study, Merck announced a worldwide withdrawal of Vioxx.
Of course one looming question is whether all the other COX-2 inhibitors could potentially cause heart problems or strokes like Vioxx. Some suggestions of a possible connection between Bextra (Valdecoxib) and an increased incidence of cardiovascular events in certain patient populations have been raised, Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib after Cardiac Surgery.
This study led the U.S. FDA to issue a warning that Bextra should not be used in patients undergoing heart bypass surgery. The FDA also strengthened warnings regarding potentially serious skin reactions - Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis - that are rare potential side effects from Bextra. Despite calls by some consumer groups for a Bextra recall, neither Pfizer of the FDA has taken this action.
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