Stevens-Johnson Syndrome (SJS) Information
Although the cause isn't always clear, Stevens-Johnson syndrome usually is a specific type of allergic reaction in response to medication or infection. An emergency medical condition, Stevens-Johnson syndrome requires hospitalization. Treatment focuses on eliminating the underlying cause, if possible, controlling symptoms and minimizing complications. Recovery after Stevens-Johnson syndrome can take several weeks to several months, depending on the severity of your condition.
SJS can cause serious eye problems, such as severe conjunctivitis; iritis, an inflammation inside the eye; corneal blisters and erosions; and corneal holes. In some cases, the ocular complications from SJS can be disabling and lead to severe vision loss. The most commonly cited cause of SJS is an adverse allergic drug reaction. Almost any drug--but most particularly sulfa drugs--can cause SJS. The allergic reaction to the drug may not occur until 7-14 days after first using it. SJS can also be preceded by a viral infection, such as herpes or the mumps, and its accompanying fever, sore throat, and sluggishness. Treatment for the eye may include artificial tears, antibiotics, or corticosteroids. About one-third of all patients diagnosed with SJS have recurrences of the disease. SJS occurs twice as often in men as women, and most cases appear in children and young adults under 30, although it can develop in people at any age.
According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). This medication, made by the drug company Cephalon, Inc., is prescribed to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder.
NEXIUM has been linked to Stevens Johnson Syndrome and Toxic Epidermal Necrolysis
The safety of NEXIUM was evaluated in over 15,000 patients (aged 18-84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. Adverse events that were reported as possibly or probably related to NEXIUM include dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculopapular, and skin inflammation. Since being launched onto the open market and sold to unsuspecting, innocent consumers, post-marketing reports have found Nexium linked to both Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Some of the reactions have been fatal.
What is Stevens-Johnson Syndrome (SJS)? What are some SJS side effects?
Stevens-Johnson Syndrome (SJS) is an auto-immune, exfoliative disorder of the skin and the mucous membranes usually caused by an adverse drug reaction. It is characterized by an extremely painful blistering skin rash, peeling skin, and blistering sores in the mucous membranes including the eyes, mouth, nostrils, throat, and anal and genital areas. In the more severe forms of the disease, the skin peels off in sheets from large areas of the body, similar to a serious burn injury. The eyes are often badly affected. Stevens-Johnson Syndrome is often caused by an allergic reaction to a drug or medication. Bextra, the popular anti-inflammatory arthritis medication, as well as Daypro and Feldene have been associated with Stevens-Johnson Syndrome as have many other non-steroidal anti-inflammatory drugs (NSAIDs) such as Motrin. Sulfa-based antibiotics, some seizure medications and many other drugs have also been associated with SJS.
Adverse drug reactions are the 4th leading cause of death in North America.
Certain prescription pain relievers, including those from the COX-2 inhibitor class, such as Bextra (valdecoxib) and Celebrex (celecoxib), have also been associated with SJS and TEN. In 2002, the FDA received reports from Pharamcia, the maker of Celebrex, documenting a number of reported cases of SJS and TEN among Celebrex users. More recently, reports have surfaced about the relation of Bextra to SJS and TEN. Indeed, despite these reports and more stern warnings, the FDA continues to receive reports of SJS and TEN in patients taking Bextra and Celebrex. The FDA suggests that patients with sulfa drug allergies should not take these drugs.
Drug companies have a responsibility to protect their drug users from adverse reactions. While all potential side effects cannot be anticipated or prevented in all patients, it is important that patients and physicians have adequate knowledge to prevent as many cases of serious side effects, such as Stevens-Johnson Syndrome or toxic epidermal syndrome, as possible. Since these drug side effects can cause debilitating injury or even death, the drug companies should be held responsible for the damages to the patient and to the patients' family members after such tragedies. SJS or TEN Lawsuits against drug makers for wrongful death or for negligence can help compensate the victims of these disorders and their families.
Drug reactions are one of the leading causes of death in the United States. However, less than one percent of adverse drug reactions are reported to the FDA because there is no mandatory reporting system in effect for postmarketing adverse drug reactions. Once a drug goes to market there is little done to study and/or prevent adverse reactions. Because the information is not made available to doctors, they may misdiagnose drug-related TEN/ SJS reactions as something else, wasting precious time as the disease ravages its victims.
In fact, many doctors do not recognize the signs and symptoms of Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS) until it is too late. Unfortunately, for several reasons including inadequate warnings and lack of awareness, doctors continue to give victims of TEN / SJS more of the drug causing the life-threatening reaction --doing more harm, which could end up killing patients. Consumers cannot rely upon the FDA, their own physician nor pharmaceutical companies manufacturing various drugs (i.e. "Big Pharma") to protect them from drug reactions.
Stevens-Johnson Syndrome Frequently Asked Questions
What is Stevens Johnson Syndrome (SJS)?
Stevens Johnson Syndrome (SJS), also referred to as EM-major, is an immune-complex-mediated hypersensitivity condition (serious skin reaction) that is typically caused as an adverse reaction to certain drugs, like Bextra. It can, in its most severe form, be fatal; eliciting fatal results in approximately 3% to 15% of sufferers. It commonly causes swelling of the mouth, throat, anogenital region, intestinal tract, and the lining of the eyelids. Stevens-Johnson Syndrome is viewed to be a more severe type of erythema multiforme (hence the EM-major classification) and typically affects people over the age of 40; however, SJS cases have been reported in children as young as three months old.
What are the symptoms of Stevens Johnson Syndrome?
People with Stevens-Johnson Syndrome may have purplish or red lesions that may be flat or small and raised. The lesions may turn into fluid-filled blisters. Stevens-Johnson syndrome can also cause blisters or bleeding in the mucous membranes of the lips, mouth, eyes, nasal passages, and genitals. If the affected membranes become infected, abnormalities in the affected area (especially the eyelids) may occur.
Does Bextra or Celebrex cause Stevens Johnson Syndrome?
Some researchers feel that Stevens-Johnson Syndrome may be an allergic reaction to a drug, while others maintain it is its own syndrome. However, since there have been incidences of Stevens-Johnson Syndrome in patients taking NSAIDs, like Bextra & Celebrex, it is likely these patients are having an allergic reaction to the COX-2 inhibitor drugs when they develop Stevens-Johnson Syndrome.
What is Toxic Epidermal Necrolysis (TEN)?
Toxic epidermal necrolysis (TEN), also known as Lyell's Syndrome, is the most serious of the three related Stevens-Johnson Syndrome skin diseases. It is characterized by involvement of more than 25 percent of a patient's skin as well as eruptions of the mucous membranes (mucosa). In this form of Stevens-Johnson Syndrome, the skin peels off in large sheets. Usually, fever and feelings of ill-health are present. TEN resembles severe burn injuries all over the body and is fatal in up to one-third of cases. TEN can also be caused as an allergic reaction to certain drugs, like Bextra.
What are the symptoms of Toxic Epidermal Necrolysis?
People with toxic epidermal necrolysis develop blisters that cover 30% or more of their bodies. The skin peels and sloughs off in large amounts. The skin exposed by this sloughing is red and appears burned or scalded. The mucous membranes can be affected, especially those around the eyes. The mouth, throat, and mucous membranes of the lung may also be affected.
Does Bextra or Celebrex cause Toxic Epidermal Necrolysis?
Toxic epidermal necrolysis is believed to be an allergic reaction to drugs in the NSAID family, like Bextra & Celebrex. Bextra (valdecoxib) and Celebrex (celecoxib) are COX-2 inhibitor drugs that have been known to illicit SJS and/or TEN. Toxic epidermal necrolysis has been classified as an immunological disorder.
What is Erythema Multiforme (EM)?
Erythema multiforme (EM) is a type of skin condition that is characterized by the development of symmetrically raised red skin areas without displaying whole-body symptoms. EM is a condition that frequently occurs in children and young adults. It is the least severe of the three Stevens-Johnson Syndrome related skin disorders.
What is Erythema Multiforme Minor (EM Minor)?
Erythema Multiforme Minor (EM Minor) is the milder form of Stevens-Johnson Syndrome. Known as EM-Minor or EM, this form includes acute skin eruptions, but usually does not involve the mucous membranes.
What is Erythema Multiforme Major (EM Major)?
Erythema Multiforme Major (EM Major), which is more technically Stevens-Johnson Syndrome (SJS) involves the mucous membranes, (most commonly the mouth and eyes) in addition to the skin. Usually, fever and flu-like symptoms are present. Eye involvement is often quite serious, with blindness or other visual impairment resulting.
What is Exfoliative Dermatitis? Exfoliative Dermatitis is a generic description of the type of skin disease Stevens-Johnson Syndrome patient's suffer from.
What other names does Stevens-Johnson Syndrome go by? Other Names For Stevens-Johnson Syndrome include: Dermatostomatitis, Stevens Johnson Type; Ectodermosis Erosive Pluriorificialis; Erythema Multiforme Exudativum; Erythema Polymorphe, Stevens Johnson Type; Lyell's Syndrome; Febrile Mucocutaneous Syndrome, Stevens Johnson Type; Johnson-Stevens Disease.
