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When a Food and Drug Administration panel meets next week to discuss Cox-2 inhibitors, the focus will be on heart risks associated with the painkillers. But other serious, little-known side effects can result from these and other drugs, including a devastating and potentially deadly skin disease.
Jane Webb, age 64, took Vioxx® for years to help with her arthritis pain in her hands. In July, her doctor switched her to Bextra®, another Cox-2 painkiller, to see if it would give her greater relief. A week into taking the new drug, the retired physics professor from Newport News, Virginia, noticed red blotches on her arms. She hadn't been told of any possible skin reactions, but was worried enough to see her dermatologist. The doctor diagnosed Stevens-Johnson Syndrome (SJS), a rare illness most commonly triggered by medications. By the next day, the entire surface of her body was covered with blotches, welts, and pimple-like bumps. "They were on my face, in my hair, in my ear," said Webb.
In the list of drug side effects, skin reactions may rank low compared with more severe problems like heart attack and stroke. In severe cases, SJS, which attacks the skin and mucous membranes, can result in blindness or death.
Efforts are currently under way to raise awareness of SJS. In December, Pfizer Inc., which makes Bextra®, strengthened the label's warning on skin reactions including SJS to a so-called black-box warning. Even amid heightened concern about the side effects following the withdrawal last year of Vioxx®, SJS remains relatively unknown to the public. Doctors themselves are sometimes unfamiliar with the condition, which can lead to an initial misdiagnosis.
In theory, SJS can result from any drugs. But drugs containing sulfa, such as the Cox-2 inhibitors Vioxx® and Bextra®, have been the most frequently implicated in SJS.
According to the National Organization for Rare Disorders, SJS incidence is estimated at 2 to 7 cases per million people in the U.S. per year, or approximately 600 to 2,000 cases annually. No one tracks cases nationally, but major medical centers probably each treat 6 to 12 cases a year, some doctors say.
Classic SJS symptoms include:
Doctors say that early detection and intervention can lessen symptoms and improve the prognosis.
If you believe that you or a relative developed Stevens-Johnson Syndrome or another skin condition after taking medication please use the form below contact our law firm.
References:
"Severe Skin Disease Gets Fresh Attention Amid Worries Over Painkiller Side Effects," Wall Street Journal, Heather Won Tesoriero, February 2005.
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