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Glaxo Wellcome Ziagen

Executive Summary

Abacavir labeling changes added to black box warning, advising doctors about additional symptoms that may suggest a diagnosis of hypersensitivity, including infectious gastroenteritis and symptoms that appear to be due to another medication. Physicians are also advised that some patients developed hypersensitivity reactions after interruption and reinitiation of abacavir even if they had no prior hypersensitivity. The company sent out a "Dear Doctor" letter July 27. Another Dear Doctor letter was distributed in January informing physicians that respiratory symptoms, including sore throat, cough or shortness of breath, could indicate a hypersensitivity reaction (1"The Pink Sheet" Jan. 31, p. 20). The rate of hypersensitivity reactions continues to be 5% across all patient populations. Two to four out of every 10,000 patients who have taken Ziagen have developed fatal hypersensitivity
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