Stevens Johnson Syndrome

August 8, 2005

Her Body Burned By Drug, Not Fire18-year-old has severe reaction to prescriptionArizona Daily Star - Carla McClain05/04/04 - A beautiful 18-year-old Tucson softball player has suffered severe burns over 80 percent of her body but has been nowhere near a fire. In an extremely rare, often fatal and little known severe toxic reaction to a medical drug, Samantha Grasham's body caught fire from the inside out blistering most of her skin, as well as her mouth, throat, esophagus and airway, perhaps leaving her scarred for life. She spent nearly three weeks in the Burn Unit at St. Mary's Hospital, as doctors there worked to save her life and her skin. As happens in most of these strange cases of what is known as Stevens-Johnson syndrome, there was no warning that Grasham would react so severely to a medication. Most people never know they are at risk, and doctors often do not recognize the syndrome when they see it. Yet many common drugs including prescription painkillers and antibiotics even over-the-counter pain and fever medicines for children are linked to this "fire in the flesh." In the worst cases, people are not only scarred, but also blinded and dependent on breathing and feeding tubes if they survive. In its severe form, when the skin is literally burned off the body and even internal organs are damaged, about half die. The U.S. Food & Drug Administration has issued dozens of warnings about drugs that can trigger Stevens-Johnson syndrome (SJS) including the one given to Grasham but the warnings receive little publicity. "I think it is commonly misdiagnosed, especially in the early stages," said Dr. Norman Levine, longtime University of Arizona dermatologist, who sees about one case a year. "But a physician will seldom miss it in a very sick patient, once it has severely progressed. When that happens, it can be devastating." Although the syndrome is rare occurring at the rate of about 1 to 7 cases per million people per year some say it is starting to increase significantly as more antibiotics and anti-inflammatory drugs hit the market. "The problem is that the drugs causing this syndrome are unbelievably common things like ibuprofen, that people take every day," said Levine. "Something in the drug leads to a very inappropriate, wildly inflammatory immune response that causes the skin to die. "It's completely unpredictable. Someone can be taking a drug safely for years, then all of a sudden have a horrible reaction to it. Those who get it are not highly allergic. This is just plain bad luck." In the case of Samantha Grasham, the syndrome stopped her life cold, ending her athletic scholarship, her education, her life plans. "I was always so active and involved - in sport and games. I loved college, and traveling," she said. "Now there is nothing - just these scars all over my body." Like many victims, she now battles chronic fatigue. The former softball star at Desert View High School entered El Paso Community College in Texas last fall on a two-year athletic scholarship. But in early January, during the first day of softball practice, she had an unexpected, one-time seizure that caused her to fall and black out. After a series of tests back home in Tucson, Grasham was placed on an anti-seizure drug, Lamictal, by a neurologist, who told her she could return to school and go on with her life normally. She did, but about 10 days after starting the drug, she noticed a small rash on her arm. Though she played first base in a softball game the next day, the rash by then had spread to her arms, legs, back and face. With the rash worsening by the hour, now itching and burning, her ears and mouth starting to blister, Grasham went to urgent care in El Paso. A doctor there correctly diagnosed an allergic reaction to the drug she was taking but never told her to stop taking it the first terrible mistake. After getting an allergy medicine, she was sent home. Two days later, "my face was on fire," as Grasham describes it, and the burns were moving down her airway, interfering with her breathing. She went back to urgent care, where again no one told her to stop the drug. Instead they gave her another drug, prednisone, also linked to cases of Stevens-Johnson syndrome. The next day, her whole body now blistering and burning, her face completely inflamed, Grasham's family made an emergency trip to El Paso. "Oh my God, I couldn't even speak when I saw her. I couldn't even cry I was so shocked," said her mother, Patricia Grasham. "Her mouth was one big blister; her face was all red and swollen. Her eyes were burning so bad we had to keep wet towels on them all the way home. The blisters were all over her mouth and down her throat. She was drooling, and in so much pain." Driving straight to the emergency room at Tucson Medical Center, the family finally found out what had attacked their daughter. An emergency physician immediately diagnosed Stevens-Johnson syndrome and nailed Lamictal as the likely cause. Grasham remembers many doctors and nurses coming into her room to see this highly unusual and bizarre eruption, many of them for the first time. "Once you see the mucous membranes blistering, and you get a history of how this progressed in the patient, an emergency physician should know what they're looking at," said Dr. Ron Widman, chief of emergency services at TMC. "But this is not very common, so yes, certainly, we want our young doctors to see it." Although Grasham was finally off Lamictal, the syndrome kept worsening - possibly fueled by adding prednisone to the other drug. She was struggling to breathe as the burns marched down her respiratory tract. Two days later, on March 5, with the severity of her burns reaching second degree, Grasham had to be moved to St. Mary's burn unit. SJS patients who reach this stage of damage when more than 35 percent of the body is blistered or burned are diagnosed with toxic epidermal necrolysis, or TENS. At that point, the mortality rate is around 50 percent. But after 18 days of intensive treatment - including extremely painful debriding of her burned skin, bandaging, infection control and special nursing care, Grasham finally left St. Mary's, alive but scarred. She has continued daily treatment as an outpatient. "If only they had known what they were looking at in (El Paso) urgent care, I don't think this would have gotten so bad," her mother said. But many doctors will never see a case of Stevens-Johnson syndrome, said Dr. Jeffrey Nelson, a plastic surgeon and burn specialist at St. Mary's burn unit. Nelson, obviously familiar with it in his specialty has treated about 10 to 12 cases during his nine years at St. Mary's, with antibiotics and anti-convulsants the most common trigger. "It feels like I've seen a lot more cases in the last three years than in the three years before that, but I have no way of knowing if that is an accurate trend," he said. SJS is not a reportable disease. But warnings about the SJS-drug link have been emerging more frequently in recent years. In 1997, the Food and Drug Administration posted a warning on the drug Grasham took, Lamictal, and the drug's maker, Glaxo Wellcome, added a boxed, boldface warning to the drug's label saying the drug has caused "severe, potentially life-threatening rash, including Stevens-Johnson syndrome and, rarely, toxic epidermal necrolysis." The warning notes that the reaction is occurring in about one of every 1,000 adults taking the drug, but at dramatically higher rates in children - as high as one in 50. "Lamictal is not approved for use in patients below the age of 16," the label now reads. Today, with no scholarship, her dreams of higher educations shot, she is at a loss over her future. "I just don't know. I need to find a job," she said softly. "This is such a nightmare."

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are two forms of the skin disease that can cause rash, skin peeling, and sores on the mucous membranes. Stevens Johnson Syndrome is an immune-complex–mediated hypersensitivity disorder that may be caused by many drugs, viral infections, and malignancies. Often, the drugs causing the onset of Stevens Johnson Syndrome, such as Bextra, did not have warnings placed on their labels until recently. Patients unknowingly took these drugs and many developed the potentially fatal Stevens Johnson Syndrome. In Stevens Johnson Syndrome, a person has blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. In toxic epidermal necrolysis, there is a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening. Causes of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis are certain drugs in the following classes: nonsteroidal anti-inflammatory drugs (both prescription and over the counter), sulfa antibiotics, antibiotics, barbiturates, anticonvulsants, anti-tuberculosis drugs, and the drug allopurinol. In rare cases SJS is caused by a bacterial infection.

Causes of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Nearly all cases of Stevens Johnson Syndrome are caused by a reaction to a drug, the most common being:Nonsteroidal anti-inflammatory drugs (NSAIDs) Bextra (valdecoxib) Daypro (oxaprozin) Arava (leflunomide) Celebrex (Celecoxib) Vioxx (Rofecoxib) Clinoril (Sulindac) Oxicam Naprosyn Enbrel (Etanercept) Feldene (piroxicam) Remicade (Infliximab) Ibuprofen (Motrin, Advil), acetominophen (Tylenol), and Naproxen Sulfa drugs Sulfamethoxazole Sulfacoxine Sulfasalazine Co-trimoxazole (Bactrim, Cotrim, Septra, Bethaprim, Sulfamethoxazole and Trimethoprim, Sulfatrim) Pyrimethamine Antibiotics Penicillins Amoxicillin Ampicillin Peperacillin Cepahlosporins Cephaloxin Erythromycin Ciprofloxacin Vancomycin Tetracycline Doxicillin Minacycline Zithromax Barbiturates Anticonvulsants Phenytoin Carbamazepine Dilantin Phenobarbital Valporate Allopurinol Anti-Tuberculosis Rifampin Ethambutol Streptomycin In many countries, increasing rates of skin eruptions are attributed to (NSAIDs). It has been reported in the medical literature that some NSAIDs that have a long half-life carry a higher risk of SJS or TEN. In rare cases SJS is caused by a bacterial infection. A cause cannot be always be identified for SJS. The disorder occurs in all age groups but is more common in older people, probably because older people tend to use more drugs. The disorder is also more likely to occur in people with AIDS. Patients with severe SJS die in 3-15% of cases. Males with SJS outnumber females by 2:1. Most Stevens Johnson Syndrome patients are in the second to fourth decade of their lives. There have been some cases reported in children as young as 3 months.If you developed Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, or other skin conditions while taking any of the above medications, contact attorney for a FREE & CONFIDENTIAL legal case evaluation. You may have a case against the manufacturers.

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August 9, 2005

OMG! Now I know why I had that awful hideous rash that I wanted to cut off my body. The doctor had prescribed Phenobarb for me (why?) This was way back in '63. I was about 3 months pregnant with my first child. Was this a usual drug to give a pregnant woman? It itched so bad like nothing I'd ever experienced.. It was all over my body. I phoned the doctor after three days of hell and he immediately said to stop taking the Phenobarbitol. I never did know why. Within a couple of days I was ok again. I'm so glad I didn't keep on taking it. We need to be so careful. Doctors don't always know the side effects of these drugs that they willynilly prescribe to their patients.

Jen