The FDA has recently issued a warning about serious and potentially fatal liver and infectious side effects associated with Arava. In addition to liver side effects, Arava has been linked to life threatening infections including sepsis. Sepsis is a severe illness caused by overwheming infection of the bloodstream by toxin-producing bacteria.
In recent studies Arava has been linked with Stevens Johnson Syndrome. Stevens-Johnson syndrome is a potentially life-threatening form of another condition known as erythema multiform.
Stevens-Johnson syndrome is an acute skin condition in which the patient develops multiple red and purple blotches on the skin of the palms, soles, backs of the hands and feet and the "upper surfaces" of the arms and legs. There may also be raised bumps, tiny blisters and large blisters.
The characteristic lesion of Steven Johnson syndrome is, however, the target lesion. Target lesions have a dark, raised center (either a papule or vesicle) surrounded by a pale ring, which in turn is surrounded by a red ring. The resemblance to a bull's eye accounts for the name "target lesion."
Stevens-Johnson syndrome is a severe form of erythema multiform. The mucous membranes (of the mouth, airway, eyes, urethra and vagina) are afflicted with vesicles and bullae. Fever, chills, headache and an all-around uncomfortable feeling (malaise) accompany these lesions.
In particularly severe cases, the kidneys, lungs and digestive tract may also develop these lesions. Such patients require hospitalization for intravenous fluids (to avoid dehydration), aggressive local care for the individual lesions (to minimize the risk of secondary infections), pain medication, and intravenous steroids (to reduce inflammation).
The severity of this illness is quite variable; some patients will recover in two weeks, while others may remain ill for six weeks or more.
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