Stevens Johnson Syndrome

What is Bextra?

Bextra, also known as Valdecoxib, was approved by the FDA in 2001 for the treatment of pain, tenderness, and swelling caused by osteoarthritis and adult rheumatoid arthritis. Bextra is supposed to decrease your level of suffering, but for some people it brought about a whole new range of problems.

Belonging to a class of nonsteroidal anti-inflammatory medications (NSAIDs) called COX-2 inhibitors, Bextra is a compound that blocks the COX-2 enzyme, the prime cause of pain and inflammation in arthritis. In some people, especially those with allergies to sulfonamides, Bextra has shown far more dramatic side effects than first believed to be capable of. Sadly, some of those side effects could prove fatal.

Who is Responsible for Stevens Johnson Syndrome from Bextra?

When a popular drug is shown to have a potentially dangerous side effect, such as Stevens Johnson Syndrome, there are usually a host of factors that come together in laying the blame for Stevens Johnson Sydrome. These sometimes make it very hard to determine who exactly will be liable in a lawsuit, a situation that causes lengthy delays in patients achieving justice, but in the case of Bextra things are far simpler. There are only two organizations responsible for the problematic side effects, and those organizations are the corporate drug giants Pharmacia and Pfizer.

Two of the world’s largest drug companies, Pharmacia and Pfizer are responsible for the marketing of Bextra as a safe drug for the prevention of arthritis pain, and as such are compelled to not only extensively test the drug, but also make the FDA aware of any potential side effect problems, such as Stevens Johnson Syndrome, prior to its release.

Clearly Pharmacia and Pfizer either didn’t research hard enough to discover the potential skin problem side effects, including Stevens Johnson Syndrome, that are now afflicting some Bextra users, or did indeed have the information but elected not to supply it to the FDA until well after the drug was approved for sale.

Whatever the true situation, the problems encountered by users before the ‘new warning’ went out leave the company wide open as a target for lawsuits from Bextra using sufferers of Stevens Johnson Syndrome, toxic epidermal necrolysis and exfoliative dermatitis, as well as those who’ve suffered other complicated allergic reactions to the drug.

Additionally, after the FDA refused Pharmacia’s request to approve Bextra for use in situations of acute pain relating to impacted molars (Bextra is only permitted for chronic pain related to arthritis, osteoporosis and menstrual cramps), the company partially funded a research study that suggested the drug would be useful in fighting acute dental pain. That study duly found its way into dental journals and the company was sued for allegedly secretive encouragement of ‘off label’ uses and attempting to circumvent the FDA’s refusal.

What is the Problem?

Originally, Bextra packages included a warning of side effects including standard ailments such as stomach pain, diarrhea, heartburn, back pain, headache, nausea, and upper respiratory infection. In November 2002 the United States Food and Drug Administration (FDA) and Bextra marketers Pharmacia/Pfizer strengthened the ‘Contraindications, Warnings, and Adverse Reactions sections of Bextra’s prescribing information.

The FDA has received about 20 reports of serious reactions to Bextra, including the skin diseases Stevens Johnson Syndrome, toxic epidermal necrolysis and exfoliative dermatitis, plus allergic reactions among Bextra users since sales began in March. These situations can not be taken lightly, and in fact some instances are considered serious and life threatening. Perhaps even more worrisome, these side effects occurs both in patients with and without a history of allergic reactions to sulfonamides. When the FDA made its new warnings about Bextra, it estimated between 800,000 to one million people had taken the drug since it first went on sale.

And Bextra isn’t alone. Other COX-2 inhibitors, such as Celebrex and Vioxx, also have potentially damaging side effects. While makers of Celebrex boasted that it doesn’t create the heart problems that Vioxx can, makers of Vioxx bragged that unlike Celebrex, Vioxx doesn’t cause stomach ulcers. All of which is little comfort for the potentially thousands of people who’ve been adversely affected by the three.

In short, the potential downside of using Bextra, Celebrex, or Vioxx could well prove far worse than the original condition requiring it.

What is the What is a Bextra Stevens Johnson Syndrome reaction or TEN reaction?

Stevens-Johnson Syndrome, also known as (SJS) is a potentially deadly skin disease that usually results from a drug reaction. SJS is related to a similar disease called Toxic Epidermal Necrolysis. SJS results from a sulfa drug-related allergic reaction.

Both SJS (Stevens Johnson Syndroe) and TEN (Necrolysis) can be deadly. Even when not fatal, SJS and TEN are extremely painful. SJS and TEN are caused by an allergic reaction to a drug containing sulfa. Bextra contains sulfa and causes Stevens Johnson Syndrome.

Other drugs that have been linked to Stevens-Johnson Syndrome, including:

• Allopurinol
• Bextra
• Carbamazepine
• Phenytoin
• Sulfa antibiotics
• SJS can cause severe pain, not to mention the visual stress and anxiety.

What is being done?

Though Bextra continues to be prescribed and sold at an increasingly growing rate, Pharmacia and Pfizer were recently compelled by the FDA to strengthen the ‘Contraindications, Warnings, and Adverse Reactions’ sections of Bextra’s prescribing information to include details of the potentially damaging ‘rare skin disease’ side effects that had come to light – Stevens Johnson Syndrome.

But that doesn’t mean the issue is over. In fact, the FDA admitted that up to a million people used Bextra before the warnings were changed, all of which may have suffered problems such as Stevens Johnson Syndrome from using Bextra, or be suffering those problems to this day. These people, in the opinion of many in the legal profession, were misinformed, lied to, and/or ultimately harmed through no fault of their own due to either the inadequate testing procedures put in place by the makers of Bextra, or through the failure to adequately reveal the Stevens Johnson Syndrome results of their testing.

Across the nation, victims of Bextra’s unexpected side effects are preparing to launch Bextra case legal actions in order to receive due compensation for their pain and suffering as a result of Stevens Johnson Syndrome. If you believe that Bextra may have been responsible for your own ill health or the symptoms of Stevens Johnson Syndrome to someone close to you, we invite you to contact our representatives at your earliest convenience to explore your Bextra case.

First of all, stop taking Bextra the moment you encounter any negative reaction.

Keep records of when you first started using Bextra, how often you’ve been taking it, any subsequent trips to the doctor, any and all blood work done; then take note of how your condition changes when you stop taking Bextra.

Perhaps most importantly – talk to one of our representatives. There’s no commitment and no cost. Just give us a call and we’ll discuss your options.

Simply call us toll-free at 1-866-761-1385 and we’ll help you decide if you have a case, explain our process, and try to give you as much assistance as possible.

FAQ’s

What is Bextra?
Bextra is a medical compound intended for the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, as well as the treatment of primary dysmenorrhea (the pain associated with menstrual cramping).

What is Valdecoxib?
Valdecoxib is, essentially, Bextra. To be precise, it’s the generic scientific term for the compound that is marketed to the American public as Bextra.

What heart problems are associated with Bextra?
The heart valve abnormalities that have appeared in some diet drug users occur in the two valves located on the left side of the heart. These valves are known as the aortic valve and mitral valve. In some diet drug users, one or both of the valves developed lesions that prevent the valves from closing properly. The blood then flows backwards, creating a condition known as “regurgitation”.

According to a recent study, Bextra is assocaited with heart attacks. The New York Times recently published an article about Bextra heart attacks that discusses this study. (November 11, 2004).

Is Bextra the same as Celebrex and Vioxx?
No, Bextra is considered to be the ‘next generation’ of Celebrex.While all three are known as ‘Cox-2 inhibitors’, Bextra is seen as an upgrade over Celebrex because Bextra users enjoy far fewer side effects in terms of the gastrointestinal system. Vioxx users, on the other hand, have been known to experience side effects that include heart issues, so you can see why people jumped on Bextra when it was released – and why Pharmacia/Pfizer were so keen to get it out there. The problem is, while Bextra doesn’t have the same side effects as the other two drugs, it has different side effects – and those side effects weren’t known when the drug was first released to the public.

Has Bextra been removed from circulation?
No, Bextra is still being prescribed as a painkiller, albeit with label warnings that are far more wide-ranging than those prior to November 2002. People who choose to take Bextra despite the risks displayed on the label do so at their own risk, but those who took the drug prior to the expansion of the label warnings may well have a case.

I have Sulfa allergies – should I be taking Bextra?
Most definitely not. Since November 2002 (many months after they started marketing Bextra), Pharmacia has been warning doctors not to give the drug to patients who were allergic to sulfa drugs. Sadly, this warning came too late for those who took Bextra before that date, or, more recently, where doctors failed to make themselves aware of the expanded warnings.

Scientific evidence also shows that Celebrex users who have sulfa allergies are also at similar risk.

What is Stephens Johnson Syndrome?
Stevens Johnson Syndrome is an extreme allergic reaction to chemicals. Common causes include the drugs Arava (leflunomide), some painkillers, and many antibiotics. Unfortunately, Bextra has now been added to the list of chemicals that can cause this potentially life threatening syndrome.

Symptoms of Stevens Johnson Syndrome include blistering, fever, coughing, general malaise, swelling and lesions of gums, tongue, or lips, excessive tearing up of, or “stickiness” of, the eyes, and sores in the genital tract that cause painful urination.

Should Bextra be taken by nursing mothers?
Most definitely not. Bextra may or may not be secreted in human breast milk (the research has yet to be done on this possibility), but it is known to be secreted through the breast milk of rats. Along the same lines, it should definitely not be used in the third trimester of pregnancy.

What other side effects can I expect from Bextra?
The majority of the side effects associated with Bextra are not considered serious, but they are certainly annoying for those experiencing them. The most frequently reported side effect include upset stomach, nausea, diarrhea, and/or headaches.

More serious side effects include blood in urine, black, tarry stools, dark yellow or brown urine, difficulty breathing, fast heartbeat, skin rash, hives, redness, blistering, peeling or itching, stomach tenderness, pain, bleeding, or cramps, unexplained weight gain or edema, and a yellowing of the eyes or skin.

Signs of a possible allergic reaction include skin rash, swelling and breathing difficulties. If you experience these symptoms, report them immediately to a doctor.

Resources on the web

RXList.com’s information on the side effects of Bextra:
http://www.rxlist.com/cgi/generic/bextra_ad.htm

The official web presence of the Bextra brand:
http://www.drugs.com/bextra.html

Medical Information

Bextra can cause extreme side effects, including (but not limited to) the following:

Anaphylaxis is a sudden, severe, potentially fatal, systemic allergic reaction involving various areas of the body such as the skin, respiratory tract, gastrointestinal tract, and cardiovascular system. Unlike Stevens Johnson Syndrome, these symptoms occur within minutes and up to two hours after contact with the allergy-causing substance, but in rare instances may occur up to four hours later.

Angioedema refers to swelling that occurs in the tissue just below the surface of the skin. It generally results from an allergic reaction to either a food or medication. It may be a sign of an underlying condition such as leukemia or Hodgkin’s disease. This is often associated with Stevens Johnson syndrome.

Toxic Epidermal Necrolysis is a life-threatening skin disorder characterized by blistering and peeling of the top layer of skin. This disorder can be caused by a drug reaction to penicillin but has now been linked to Bextra.

Erythema Multiforme (EM) is an acute self-limited eruption characterized by a distinctive clinical eruption, the hallmark of which is the iris or target lesion. EM may be present within a wide spectrum of severity. EM minor represents a localized eruption of the skin with mild or no mucosal involvement, corresponding to the initial description of von Hebra. EM major and Stevens Johnson syndrome (SJS) are more severe mucosal and skin diseases as well as potentially life-threatening disorders.

Generalized Exfoliative Dermatitis is a severe inflammation of the entire skin surface due to a reaction to certain drugs, or as a result of complications from another skin condition. In some cases, lymph node cancer (lymphoma) causes generalized exfoliative dermatitis.

Heart Attacks and Strokes A recent study (October/November 2004) showed that certain patients were at higher risk for heart attacks as a result of taking Bextra. An initial study last year raised similar concerns in the same kinds of patients. Coupling this with the information about Vioxx, anyone taking a Cox-2 inhibitor like Bextra should be concerned. Stevens Johnson Syndrome. Common causes are the drugs including Arava (leflunomide), painkillers, and antibiotics. Bextra has now been linked to this potentially life threatening syndrome. Symptoms of Stevens Johnson Syndrome are blistering, fever, cough, malaise, swelling and lesions of gums, tongue, or lips and excessive tearing or “stickiness” of eyes and sores in the genital tract causing painful urination.

Patients who have severe allergies to antibiotics should not use Bextra. If you develop any of the following symptoms consult your doctor immediately.

More serious side effects that you should report immediately include blood in urine, dark yellow or brown urine; black tar-like stools; difficulty breathing, fast heartbeat; skin rash, hives, redness, blistering, peeling or itching; stomach tenderness, pain, bleeding, cramps; unexplained weight gain or edema; and yellowing of eyes or skin.

Do not take Bextra if you had an allergic reaction to aspirin or other NSAID. Bextra should also be avoided if you have a history of peptic ulcer or GI bleeding.

The effects of Bextra have not been studied in children, and should not be used in the third trimester of pregnancy. Similarly, it is not known if Bextra is excreted in breast milk, though it is excreted in the breast milk of rats, so the drug should not be taken by nursing mothers.

You may be required to have frequent blood work while on Bextra. It is very important that you keep all lab and doctor’s appointments. If you get black, tarry stools or vomit what looks like coffee grounds, call your doctor at once. You may have a bleeding ulcer.

If you already had Stevens Johnson Syndrome symptoms diagnosed and believe the use of Bextra to be a contributing factor, fill out the form below to immediately contact our representatives and discuss your options.