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Steven Johnson Syndrome

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In 3-15% of cases, patients with severe Stevens Johnson Syndrome will die.

Quick Fact - It is estimated that every year approximately 200,000 Americans die from prescription drug adverse reactions and side effects which is more than Americans who die from illegal drugs each year.

The popular COX-2 inhibitor BEXTRA ® has been linked to Heart Attack, Stroke, Stevens Johnson Syndrome, and other skin hypersenstivity disorders. Stevens Johnson Syndrome is an extreme allergic reaction to chemicals. BEXTRA ® has now been linked to this potentially life threatening syndrome. Prescription NSAIDs, such as BEXTRA ® (valdecoxib), are one of the leading classes of drugs that cause Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis ( TEN) reactions. 

Stevens Johnson Syndrome - Cause

The most common cause associated with Stevens - Johnson syndrome in adults is drug therapy.  Stevens - Johnson syndrome is an acute skin condition which begins as a red rash on the skin. This usually occurs one day to four weeks after beginning the drug therapy. The rash can occur anywhere on the body, including the soles of the feet and the palms of the hands. The red rash can worsen to include small and/or large fluid filled blisters. These blisters usually progress to resemble burns because actual skin loss has occurred. Secondary infections are a potential severe complication of any skin damage. Permanent damage, scarring and even death can occur in the severe forms of these syndromes.

The most severe form of Stevens - Johnson syndrome can include involvement of the mucus membranes of the digestive tract, airway, eyes and genital and urinary tracts. In some cases, the kidneys, lungs and digestive tract develop the same type of lesions that can occur on the skin, requiring hospitalization and supportive care. The severity of this illness is variable and can be life threatening. The length of recovery is dependent on the severity of the illness.

Stevens Johnson Syndrome - Trigger

BEXTRA ®, which often triggers Stevens Johnson Syndrome, is a COX-2 Inhibitor prescribed for the joint pain of osteoarthritis and adult rheumatoid arthritis, as well as menstrual cramps. In 3-15% of cases, patients with severe Stevens Johnson Syndrome will die.

Effects of Stevens Johnson Syndrome/Toxic Epidermal Necrolysis:

  • Adverse drug reactions.
  • Painful Blistering of the skin and mucous membrane involvment.
  • In many cases proceeded with flu like symptoms and high fever.
  • As it evolves the skin literally sloughs off.
  • Ocular involvement includes severe conjunctivis, iritis, palpebral edema, conjunctival and corneal blisters and erosions, and corneal perforation.

Bextra - Pfizer Warnings

In October 2002, Pharmacia (Pfizer), the manufacturer of BEXTRA ®, included a warning about serious skin reactions in their BEXTRA ® product insert revision. Prior to that, no warning was provided in the BEXTRA ® package insert.

Pharmacia sent letters on November 13, 2002 to healthcare professionals about the new warnings: BEXTRA ® causing Stevens-Johnson Syndrome, erythema multiforme, toxic epidermal necrosis, exfoliative dermititis, anaphylactoid reactions and angiodema. They also warned that BEXTRA ® should not be given to patients who are sulfa allergic, as these reactions could be life threatening.

Stevens Johnson Syndrome Symptoms & Treatment

  • Stevens Johnson Syndrome and toxic epidermal necrolysis usually begin with fever, headache, cough, and body aches, which may last from 1 to 14 days.
  • Then a flat red rash breaks out on the face and trunk, often spreading later to the rest of the body in an irregular pattern.
  • The areas of rash enlarge and spread, often forming blisters in their center. The skin of the blisters is very loose and easy to rub off.
  • In toxic epidermal necrolysis, large areas of skin peel off easily. In many people, 30% or more of the body surface peels away. The skin loss in toxic epidermal necrolysis is similar to a severe burn and is equally life threatening. Huge amounts of fluids and salts can seep from the large, raw, damaged areas. A person who has this disorder is very susceptible to infection at the sites of damaged, exposed tissues; such infections are the most common cause of death in people with this disorder.
  • The affected areas of skin are painful, and the patient feels ill with chills and fever.
  • The hair and nails sometimes fall out.
  • Blisters break out on the mucous membranes lining the mouth, throat, anus, genitals, and eyes. The damage to the lining of the mouth makes eating difficult, and closing the mouth may be painful, so the person may drool.
  • Ocular involvement includes severe conjunctivis, iritis, palpebral edema, conjunctival and corneal blisters and erosions, and corneal perforation. The eyes may become very painful, swell, and become so filled with pus that they seal shut. The corneas can become scarred and there may be loss of vision.
  • Esophageal strictures may occur when extensive involvement of the esophagus exists. Mucosal shedding in the tracheobronchial tree may lead to respiratory failure. Mucosal pseudomembrane formation may lead to mucosal scarring and loss of function of the involved organ system.
  • The urethra may also be affected, making urination difficult and painful. Vaginal stenosis and penile scarring have been reported. Renal complications are rare.
  • Sometimes the mucous membranes of the digestive and respiratory tracts are involved, resulting in diarrhea and difficulty breathing.

Treatment & Healing

It is important that people with Stevens-Johnson syndrome or toxic epidermal necrolysis are hospitalized. Drugs suspected of causing the disorder should be immediately discontinued. Some patients are treated in a burn unit, even though the skin will grow back on its own during recovery and skin grafts will not be required. Fluids and salts, which are lost through the damaged skin, are replaced intravenously.

Some in the medical community support the use of corticosteroids to treat the disorder, believing that large doses within the first few days can be beneficial. However, because corticosteroids suppress the immune system, there is the potential for serious infection. If infection develops, doctors give antibiotics immediately. Specific nursing care and adequate topical management reduce associated morbidity and allow a more rapid re-epithelialization of skin lesions. After healing, follow-up is needed for ophthalmologic and mucous membrane sequelae. Sunblocks are recommended. Testing for glycemia must be done.

Stevens Johnson Syndrome History

In 1922, Stevens and Johnson described two children with fever and stomatitis (mouth ulcers), severe disseminated conjunctivitis (eye inflammation) and cutaneous (skin) eruptions.  It soon became evident that severe forms of Stevens Johnson Syndrome (SJS) could lead to toxic epidermal necrolysis (TEN) and that both diseases could be induced by the same drugs. Timing of Stevens Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) reaction

The reaction usually develops within 1-4 weeks from the onset of starting drug therapy. However, the prodromal or beginning symptoms can develop within hours or days and include mild rash, or mucosal lesions or fever of an unexplained origin.  Mucosal lesions include lesions of the mouth, eyes, GI and respiratory tract, anus and vagina.  If any of these symptoms occur, the drug should be discontinued immediately and you should seek medical attention. This is because, in some cases, such reactions may develop into severe, sometimes, life-threatening skin and mucous membrane reactions, such as Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

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.


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