What is Bextra?
What is the Cox enzyme?
What are NSAlDs? 
What is the problem with Bextra?
Did the Food and Drug Administration know about these allergic reactions?
What is Steven Johnson Syndrome?
What is toxic epidermal necrolysis?
What is erythema multiforme?

What is Bextra?
Bextra (Valdecoxib) is similar to Celebrex (Celecoxib) in the respect that it is a prescription COX-2 selective inhibitor nonsteroidal anti inflammatory drug (NSAID) used for the relief of pain associated with osteoarthritis (OA), rheumatoid arthritis (RA) and menstrual cramps (primary dysmenorrhea). Bextra was manufactured by Pharmacia Corporation/Pfizer, Inc., and it was approved for these purposes by the Food and Drug Administration (FDA) on November 16, 2001.  Bextra began being sold in March 2002.
Bextra, similar to Celebrex, works by inhibiting the COX-2 form of the COX enzyme to block production of prostaglandins. Prostaglandins are hormone-like substances that contribute to the symptoms of pain, fever and inflammation.
Bextra tablets for oral administration contain either 10 mg or 20 mg of the active ingredient, valdecoxib.

What is the COX enzyme?
The cyclooxygenase (COX) enzyme has two forms: COX-1 and COX-2. COX-1 is found in most cells all the time, notably the lining of the stomach where it regulates acid production. COX-2 is not normally present in most cells.  It only appears when things are going wrong in the body. As a result, COX-2 was thought to be responsible for the bad effects of the COX enzyme- pain and inflammation. Vioxx was developed based on this belief that COX-2 was responsible for the bad effects of the COX enzyme and to reduce or even eliminate the gastrointestinal risks involved with the non-selective (traditional) NSAIDs like Aspirin (acetylsalicylic acid, ASA), Ibuprofen, Nabumetone and Naproxen, that inhibit both COX-1 and COX-2 enzymes. However, COX-2 serves other purposes besides its role in inflammation. Among the purposes the COX-2 enzyme serves is that it plays a major role in controlling the cardiovascular system-stopping platelets from forming blood clots (thrombi -plural form of thrombus) in the heart, and preventing damage to vessels.

What are NSAIDs?
NSAIDs are a large group of drugs that have pain- relieving (analgesic) and fever-reducing (antipyretic) effects, as well as the effect of 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 CCX-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 (CA) and Rheumatoid Arthritis (RA) being the most common forms).
• Back-pain-and-sciatica-(pain-down-into-the leg, which travels below the knee, and may involve the foot -may occur alone or accompanied by low back pain): 
•  Sprains, strains and rheumatism (a chronic autoimmune disease with inflammation of the joints and marked deformities); 
•  Dental pain;
• Post-operative pain;
• Menstrual cramps (primary dysmenorrhoea - mild, and menorrhagia - heavy);
• Pain from kidney stones (renal colic);
• Reduction of fevers;
• Migraines (recurrent severe headaches generally accompanied by an aura (classic migraine), nausea, vomiting, and dizziness);
• Other painful conditions, particularly those with symptoms of inflammation.
  NSAIDs come in different formulas and in over-the- counter (OTC) and prescription strengths. Some may work better for you than others. Your physician can help you find the dose and medication that works best for you.

What is the problem with Bextra?
Preliminary studies have indicated that Bextra (valdecoxib), an arthritis drug manufactured by Pfizer, Inc., could potentially be one of the leading causes of Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis and erythema multiforme (EM) due to drug allergy reactions. These studies also indicate that Bextra, like Vioxx (another COX-2 inhibitor that was recently pulled from the shelves by its manufacturer, Merck & Co. Inc.), may be linked with greatly increased risks of cardiovascular (CV) events such as heart attacks and strokes.

Did the Food and Drug Administration (FDA) know about these allergic reactions?
Yes. The FDA announced on November 15, 2002, that it had received about 20 reports of serious reactions, including skin diseases Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis, and erythemamutliforme (EM)] and hypersensitivity reactions (anaphylactic reactions and angioedema). Pharmacia had issued a Dear Healthcare Professional letter two days earlier regarding these conditions. Previously, on October 22, the European Medicines Evaluation Agency (the European counterpart to the FDA) issued a public statement warning of the same side effects due to taking Bextra. Unfortunately, all this came too late for Bextra patients who have been suffering from the serious and potentially fatal drug allergic reactions like Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN ), exfoliative dermatitis, and erythema multiforme (EM).

What is Stevens Johnson Syndrome?
Stevens Johnson Syndrome (SJS) is an immune- complex-mediated hypersensitivity disorder that may be caused by a reaction to drugs (including Bextra), viral infections, and malignancies. It is a rare disorder that can be life-threatening. A person with Stevens Johnson Syndrome has blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. Common symptoms include: 

• Rash, blisters, or red splotches on skin;
• Persistent fever;
• Blisters in mouth, eyes, ears, nose, genital area;
• Swelling of eyelids, red eyes;
• Conjunctivitis;
• Flu-like symptoms.

Symptoms are not the same for everyone. Additionally, target lesions are not always seen in Stevens Johnson Syndrome.  The manufacturers of drugs (such as Bextra) that carry the risk of Stevens Johnson Syndrome did not include any warnings on their labels regarding these risks until recently. As a result, many regular users have been unknowingly exposed to a potentially fatal disease. Did you take Bextra? Have you been diagnosed with Stevens Johnson Syndrome? It may be linked with your use of Bextra. Contact Jeff Lowe, a qualified and experienced Bextra lawyer.  Don’t wait until its too late to have your claim evaluated.

What is toxic epidermal necrolysis?
Toxic epidermal necrolysis (a form of SJS) is a life-threatening skin disorder characterized by blistering of the mucous membranes (similar to Stevens Johnson Syndrome) and the top layers of skin peeling off in sheets, leaving large areas that look scalded.  As a result, fluids and scales ooze from the raw and damaged areas, which could potentially get infected. This condition can be caused by a drug reaction or another disease and about 1/3 of all diagnosed cases are a result of unknown causes. The following are the most common symptoms of toxic epidermal necrolysis:

• A painful, red area that spreads quickly;
• The top layer of skin may peel without blistering;
• Scalded-looking raw areas of flesh;
• Discomfort (malaise);
• Fever;
• Condition spread to eyes, mouth, and genitals.

Each person’s symptoms can vary and the symptoms may resemble other dermatologic conditions. Contact your health care provider immediately if you notice any particularly unusual problems with your skin. If you are diagnosed with toxic epidermal necrolysis and you were a regular user of Bextra (or other drugs carrying a similar risk), contact Jeff Lowe for immediate legal assistance. You may have a claim for damages.

What is exfoliative dermatitis?
Exfoliative dermatitis, also known as erythroderma, is an uncommon but serious skin disorder. Generalized exfoliative dermatitis is a severe inflammation of the entire skin surface due to a reaction to certain drugs (such as Bextra), or as a result of complications from another skin condition. In some cases, lymph node cancer (lymphoma) can cause generalized exfoliative dermatitis, although the underlying cause of the disease is unknown. The following are the most common symptoms of
generalized exfoliative dermatitis:

• extreme redness of the skin;
• scaling;
• thickened skin;
• itching;
• swollen lymph nodes;
• fever;
• loss of fluids and proteins through the damaged skin.

Symptoms vary from person to person, and they may resemble other dermatologic conditions. Consult with your physician if you experience significant changes to your skin. Hospitalization is usually necessary for initial evaluation and treatment. In the hospital, special attention must be given to maintaining temperature control, replacing lost fluids and electrolytes, and preventing and treating infection. Contact Jeff Lowe for immediate legal assistance. You may have a claim for damages.

What is erythema multiforme? Erythema multiforme (EM) is a serious inflammatory skin eruption (rash) caused by allergic reactions to many different things, including prescription and over-the-counter drugs. It can affect people of all ages and is often more severe in children and young adults. Erythema multiforme often starts as a red rash on the palms, soles, and back of the hands. It can spread to the trunk, face, and mouth in severe cases. Some people only have erythema multiforme in the mouth. As the skin lesions age, they often look like small targets with purple to dusky centers surrounded by red rings. The condition can be associated with fever, muscle aches, and not feeling well.

Most cases of erythema multiforme completely recover. There may be dark marks for a few months when the patches clear up. Sometimes, the condition recurs. However, sometimes the disease can be severe enough that the person needs to be hospitalized. Erythema multiforme has been so “named because of the “multiple forms’ it appears in. Contact Jeff Lowe for immediate legal assistance.