Stevens Johnson Syndrome (SJS) Lawsuit :
What is Stevens Johnson Syndrome (SJS) ?
Stevens-Johnson syndrome (SJS) is an immune-complex–mediated hypersensitivity complex that is a severe expression of erythema multiforme. Stevens Johnson Syndrome (SJS) is also now known as erythema multiforme major (EM), leyll's Syndrome, and Toxic Epidermal Necrolysis (TEN). Stevens Johnson Syndrome typically involves the skin and the mucous membranes. While minor presentations may occur, significant involvement of oral, nasal, eye, vaginal, urethral, GI, and lower respiratory tract mucous membranes may develop in the course of the illness. GI and respiratory involvement may progress to necrosis. Steven's Johnson Syndrome is a serious systemic disorder with the potential for severe morbidity and even death.
Although Stevens Johnson Syndrome, Erythema Multiforme, Leyll's Syndrome, and Toxic Epidermal Necrolysis may be caused by viral infections or malignancies severe allergic reactions to medication is the leading cause. Medications that have traditionally been known to lead to Stevens Johnson Syndrome, Erythema Multiforme, Leyll's Syndrome, and Toxic Epidermal Necrolysis include:
- sulfonamides (antibiotics)
- penicillin's (antibiotics)
- barbiturates (sedatives)
- phenytoin - Dilantin (anticonvulsant)
More recently reports show that other drugs may also be responsible for the onset of Stevens Johnson Syndrome, Erythema Multiforme, Leyll's Syndrome, and Toxic Epidermal. Experts believe that Non Steroidal Anti-Inflammatory Drugs (NSAID's) including Daypro (Oxaprozein), the popular COX-2 inhibitors Vioxx (Rofecoxib), Celebrex (Celecoxib), and Bextra (Valdecoxib) are a leading cause of the disease. Other Non Steroidal Anti Inflammatory drugs such as Feldene (Piroxicam), Naproxen (Aleve) and Ibuprofen (Advil, Children's Advil, Motrin, Childrens Motrin and Nuprin) are also a leading cause of the disease. Other popular medications that are known to cause Stevens-Johnson Syndrome include the popular antibiotic medications Zithromax, also known as a z-pack, and Keflex (cephalexin). Coreg (carvedilol) a popular beta blocker, is also known to cause SJS.
On May 16, 2006 the FDA released an updated warning label for several prescription and over the counter (OTC) medications as a result of increased risk of developing Steven's Johnson Syndrome. The following drugs had either a new warning regarding Steven's Johnson Syndrome or additional wording:
- Tolectin 600 Tablets (Tometin Sodium)
- Tolectin DS Capsules (Tometin Sodium)
- Advil Allergy Sinus Tablets (200 mg ibuprofen / 30 mg pseudoephedrine HCI / 2 mg chlorpheniramine maleate)
- Advil Cold & Sinus Tablets (200 mg ibuprofen / 30 mg pseudoephedrine HCI)
- Advil Liqui-Gels (200 mg ibuprofen capsules)
- Advil Migraine Capsules (200 mg ibuprofen)
- Children's Motrin Chewable Tablets (50 mg ibuprofen)
- Motrin Junior Strength Chewable Tablets (100 mg ibuprofen)
- Motrin Cold & Sinus Tablets (200 mg ibuprofen / 30 mg pseudoephedrine HCI)
- Motrin IB Tablets (200 mg ibuprofen)
- Motrin Infants' Drops (50 mg / 1.25 mL ibuprofen oral suspension)
Typically, the disease process begins with a nonspecific upper respiratory tract infection. This usually is part of a 1- to 14-day prodrome during which fever, sore throat, chills, headache, and malaise may be present. Vomiting and diarrhea are occasionally noted as part of the prodrome. Mucocutaneous lesions develop abruptly. Clusters of outbreaks last from 2-4 weeks. The lesions are typically nonpruritic. A history of fever or localized worsening should suggest a superimposed infection; however, fever has been reported to occur in up to 85% of cases. Involvement of oral and/or mucous membranes may be severe enough that patients may not be able to eat or drink. Patients with genitourinary involvement may complain of dysuria or an inability to void. A history of a previous outbreak of Stevens-Johnson syndrome (SJS) or of erythema multiforme may be elicited. Recurrences may occur if the responsible agent is not eliminated or if the patient is re exposed.Typical symptoms are as follows:
- Cough productive of a thick purulent sputum
- Itching
- Fever
- Headache
- Malaise
- Arthralgia
The rash can begin as macules that develop into papules, vesicles, bullae, urticarial plaques, or confluent erythema. The center of these lesions may be vesicular, purpuric, or necrotic. The typical lesion has the appearance of a target. The target is considered pathognomonic. Lesions may become bullous and later rupture, leaving denuded skin. The skin becomes susceptible to secondary infection. Urticarial lesions typically are not pruritic. Infection may be responsible for the scarring associated with morbidity. Although lesions may occur anywhere, the palms, soles, dorsum of hands, and extensor surfaces are most commonly affected. The rash may be confined to any one area of the body, most often the trunk. Mucosal involvement may include erythema, edema, sloughing, blistering, ulceration, and necrosis. The following signs may be noted on examination:
- Fever
- Orthostasis
- Tachycardia
- Hypotension
- Altered level of consciousness
- Epistaxis
- Conjunctivitis
- Corneal ulcerations
- Erosive vulvovaginitis or balanitis
- Seizures
- coma
Although mild forms of Erythema Multiforme usually resolve without difficulty in 2 - 6 weeks more severe forms may be difficult to treat. Stevens Johnson Syndrome and Epidermal Necrolysis are associated with high death rates and even with treatment the following complications may occur:
- Permanent skin damage and scarring
- Occasionally, lesions on internal organs causing:
- Pneumonitis (lung inflammation)
- Myocarditis (heart inflammation)
- Nephritis (kidney inflammation)
- Hepatitis (liver inflammation)
- Secondary skin infection
- Systemic infection
- Severe loss of body fluid resulting in shock
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