Glaxo Wellcome Ziagen
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryLabeling changes have been added to black box warning, advising that additional symptoms could suggest hypersensitivity, including infectious gastroenteritis and symptoms that appear to be reactions to another medication, the firm reports in a July 27 "Dear Doctor" letter. Labeling also has been changed to state that some patients developed hypersensitivity reactions after interrupting and restarting the agent even if they did not have prior hypersensitivity. Fatal hypersensitivity has developed in two to four of every 10,000 patients who have taken Ziage
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