Bextra (valdecoxib) is an oral medication used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. Manufactured by Pfizer Pharmaceuticals, Bextra is classified as a COX-2 selective non-steroidal anti-inflammatory drug (NSAID).
Bextra is prescribed for pain associated with arthritis, menstrual discomfort, and other ailments.
Bextra was approved by the FDA in 2001 for the relief of pain, fever, swelling, and tenderness caused by osteoarthritis, rheumatoid arthritis, and menstrual cramps (primary dysmenorrhea).
The most common side effects associated with Bextra are headache, abdominal pain, diarrhea, nausea, flatulence and insomnia.
On April 7, 2005, Pfizer withdrew Bextra from the U.S. market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.
Bextra is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use Bextra have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, alcohol usage, older age, and poor general health status.
What did the FDA’s notification of Bextra withdrawal state?
In the notification provided to healthcare professionals, the FDA stated that it “has concluded that the overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.”
What is Rheumatoid Arthritis?
Rheumatoid arthritis is a chronic, inflammatory type of arthritis that is classified as an autoimmune disease (immune cells attack the body’s own healthy tissues). The joints are primarily affected by rheumatoid arthritis, but there can be systemic effects (i.e. organs) as well. The primary symptoms associated with rheumatoid arthritis include:
- joint pain
- joint swelling or effusion
- joint stiffness
- redness and/or warmth near the joint
- restricted range of motion
Morning stiffness lasting more than an hour, involvement of the small bones of the hands and feet, extreme fatigue, rheumatoid nodules, and symmetrical joint involvement (i.e. both knees not one knee) are all characteristics of rheumatoid arthritis. Approximately 2.1 million people in the United States have rheumatoid arthritis and about 1-2 percent of the world population is affected by rheumatoid arthritis.
What is Osteoarthritis?
Osteoarthritis is one of the oldest and most common types of arthritis – is a disease that causes the breakdown of cartilage in joints leading to pain and stiffness. Osteoarthritis affects an estimated 20.7 million Americans. Although the exact cause of osteoarthritis is not known, researchers believe that heredity, obesity, injury and repeated overuse of certain joints can increase the risk of developing osteoarthritis.
Osteoarthritis can affect any joint but frequently occurs in the hips, knees and spine. The finger and toe joints can also be affected. Wrists, elbows, shoulders, ankles and jaws are rarely affected, except as the result of an injury.
What are NSAIDs?
NSAIDs are a large group of drugs that have pain-relieving and fever reducing effects, as well as reducing inflammation when used over time. The anti-inflammatory effects may take anywhere from a few days to three weeks to take effect. Non-selective (traditional) NSAIDs like Ibuprofen, aspirin, Nabumetone and Naproxen work by inhibiting both the COX-1 and COX-2 enzymes to stop the production of prostaglandins, while COX-2 inhibitors only block the COX-2 enzyme. Common uses for NSAIDs are:
- Treatment of pain and inflammation associated with arthritis (inflammation and resulting pain of one or more joints, a common characteristic of over 200 rheumatic diseases with osteoarthritis and rheumatoid arthritis being the most common forms).
- Back pain and sciatica (pain down into the leg, which travels below the knee and may involve the foot).
- Sprains, strains and rheumatism.
- Menstrual cramps (primary dysmenorrhoea – mild, and menorrhagia – heavy).
- Migraines, nausea, vomiting, and dizziness.
- Other painful conditions, particularly those with symptoms of inflammation.
Can I file a lawsuit if I have suffered damages from taking Bextra?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Bextra, you should contact your doctor immediately. You may also wish to contact an experienced Bextra lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.