Bextra® Arthritis
(800) 889-9248
After the U.S. Food and Drug Administration approved Bextra® in 2001 for treating the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, the marriage of Bextra® and arthritis is now officially over after what some patients and doctors are calling "a painful divorce." While Bextra® and arthritis were "together," Bextra® offered 24-hour arthritis pain relief in a single, daily 10-milligram dose. In clinical trials involving more than 5,000 patients, Bextra® demonstrated equal success while offering much improved gastrointestinal safety and tolerability versus conventional NSAIDs such as naproxen, ibuprofen, and diclofenac.
With the approval of Bextra® and arthritis treatment, people with arthritis pain had a new, easy treatment option. Bextra® gave arthritis patients pain relief comparable to the prescription-strength drug naproxen, but with a significantly improved gastrointestinal safety profile. What the FDA didn't realize at the time was that Bextra® also had the potential to cause heart attacks and strokes along with other cardiovascular risks.
With most patients growing weary with concern about taking Bextra®, and arthritis symptoms not getting any better, sales of Bextra® began to decrease. On April 7, 2005, the FDA asked Pfizer Incorporated to remove Bextra® from the market. While some patients taking Bextra® for arthritis looked for another treatment, doctors were in a state of confusion.
Medical professionals expressed disbelief and concern at the FDA's announcement that the prescription painkiller Bextra® would be withdrawn from the market, and that a host of other effective analgesics will now come with tough "black box" labeling warning of their potential cardiovascular and gastrointestinal risks.
While the FDA looks at the recall as a safety measure, physicians lose another instrumental drug in helping patients fight arthritis. Some physicians question whether or not the decision to prescribe Bextra® for arthritis would be better left to individual doctors instead of a federal agency.
Doctors may argue that the FDA is taking away doctor-patient decision-making. They argue that they could allow Bextra® to be sold with warnings and it would then be a doctor-patient decision. Doctors also argue that the average consumer is going to be confused and the average physician is somewhat confused about a replacement for Bextra® and arthritis treatment.
The recall of Bextra® came less than two months after expert advisory panels suggested that the COX-2 drugs Celebrex and Bextra® stay on the market, under the condition that enhanced warnings be placed on the boxes. Once the FDA asked Pfizer Inc. to remove Bextra® from the market, they also mandated strong black-box warning labels for Pfizer's Celebrex, the only drug in the COX-2 class still available to consumers.
If you or a loved one has been prescribed Bextra® for arthritis in the past and suffered a heart attack, stroke, or gastrointestinal distress, you may have a claim. While Bextra® and arthritis may have seemed like a good combination at first, the side effects have proven deadly. Contact an experienced Bextra® attorney for help with your claim and receive due compensation.
