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As previously reported, the Bextra label also includes a "black box" warning--the most serious kind--for a dangerous skin condition called Stevens-Johnson Syndrome.
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According to Pfizer (nyse: PFE - news - people ), Bextra can cause a rare but sometimes life-threatening drug reaction called Stevens-Johnson Syndrome in which the skin, mouth, and eyes can become horribly blistered.
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Chakalis later developed a constellation of ailments including Stevens-Johnson syndrome, a life-threatening skin condition that can be caused by a variety of drugs including Provigil.
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On the other hand, the risk of Stevens-Johnson Syndrome, which occurred with Incivek, is a serious concern.
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Anderson noted that many drugs have warnings in their labels about the risk of Stevens-Johnson Syndrome, but few contain a 'black box.
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The panel cited a suspected case of Stevens-Johnson syndrome, a potentially fatal skin rash, in a child taking part in a Sparlon study.
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Two weeks later she developed joint pain and blisters on her chest and arms, a condition known as Stevens-Johnson syndrome, which can be caused by an allergic reaction to antibiotics.
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The panel had not been asked to consider a second safety issue, called Stevens-Johnson Syndrome, a rare and potentially deadly skin reaction for which Bextra already has a boxed warning.
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The attention deficit hyperactivity disorder drug, which is already on the market for sleepiness under the name Provigil, had caused one possible case of Stevens-Johnson Syndrome, a rare skin reaction.
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Bextra causes Stevens-Johnson Syndrome more often than Celebrex, a similar Pfizer pain drug, and Pfizer has been in discussions with the Food and Drug Administration about how to include the risk in the drug's label.
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Incivek causes rash, which can be serious, and, in rare cases, Stevens Johnson Syndrome (SJS), a life-threatening blistering of the skin.
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