Bextra Frequently Asked Questions

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. The marketing of Bextra started 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. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.

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What is the COX enzyme?

The cyclooxygenase (COX) enzyme has two forms: COX-1 and COX-2. COX-1 is found in a lot of cells all the time, notably the lining of the stomach where it regulates acid production. COX-2 is not present in most cells normally, only appearing when things are going wrong. 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. It also serves other functions that are beyond the scope of this FAQ section to explain.

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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 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 (OA) 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. Tell your physician if you are pregnant, have high blood pressure, asthma, or a history of kidney or liver disease, or have had ulcers in the past. People over age 65 must be especially careful when taking NSAIDs. Also tell your doctor about other medications you are taking. NSAIDs may intensify or counteract the effects of some medications. Both the risk and the severity of side effects increase the longer you take NSAIDs.

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Is Bextra right for me?

You should not take Bextra if you:

  • Had asthma, hives or allergic reactions after taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) or COX-2 inhibitors. Some examples of NSAIDs are ibuprofen (Motrin, Advil), naproxen (Naprosyn, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), ketoprofen (Orudis), celecoxib (Celebrex), and rofecoxib (Vioxx). You can ask your doctor or pharmacist for a complete list of these medications;
  • Are allergic to valdecoxib (Bextra) or to any of the ingredients in Bextra.

Bextra, like all NSAID medications can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Bextra, but it can also happen suddenly. Stop taking Bextra and call your doctor right away if you get:

  • A burning stomach pain;
  • Black bowel movements that look like tar;
  • Vomit that looks like blood or coffee grounds.

Bextra and other NSAID medications can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If this happens, stop taking Bextra and call your doctor right away. Bextra can also cause fluid retention (holding of water in your body). Fluid retention can be a serious problem if you have high blood pressure or heart failure.

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What should I tell my health care provider?

Tell your health care provider if you:

  • have heart problems or high blood pressure;
  • have liver or kidney problems;
  • have or had stomach ulcers or stomach bleeding;
  • have asthma;
  • are allergic to aspirin or other NSAID medicines;
  • are pregnant or planning to become pregnant;
  • are breast-feeding.

Tell your health care provider about all the medicines that you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your health care provider may have to adjust your dose or watch you more closely if you take the following medications:

  • certain blood pressure medicines called ACE inhibitors;
  • furosemide (Lasix);
  • fluconazole or ketoconazole;
  • lithium;
  • warfarin (coumadin);
  • aspirin.

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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), 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.

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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 erythema mutliforme (EM)] and hypersensitivity reactions (anaphylactic reactions and angioedema). Pharmacia had issued a "Dear Healthcare Professional" letter two days earlier. 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), and erythema multiforme (EM).

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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. It is very important that if you are a regular user of Bextra or other drugs that could cause this potentially fatal disease that you get checked thoroughly by your health care provider immediately to help minimize the long-term effects if you are diagnosed with 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. Do you take Bextra? Have you been diagnosed with Stevens Johnson Syndrome? It may be linked with your use of Bextra. Contact one of these qualified and experienced Bextra lawyers by clicking on the panels you see on the left and right sides of this page. Don't wait until it's too late to have your claim evaluated.

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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 are a regular user of Bextra (or other drugs carrying a similar risk), contact one of the Bextra lawyers by clicking the panels you see on the left and right sides of this page for immediate legal assistance. You may have a claim for damages.

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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.

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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, particularly if the cold sore virus was the cause. 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.

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