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Relenza Dear Doctor Letter In EU Follows U.S. Advisory

Executive Summary

Glaxo Wellcome is warning European prescribers about potential side effects with Relenza one week after similar concerns were raised by FDA.

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Glaxo Wellcome Ziagen

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

Glaxo Wellcome Ziagen

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

Glaxo Wellcome Relenza

"Dear Healthcare Professional" letter sent July 10 to highlight addition of bolded warning to zanamivir labeling. The warning addresses events of bronchospasm and decline in lung function reported in some patients, and advises against Relenza administration to patients with underlying airway disease such as asthma or chronic obstructive pulmonary disease (1"The Pink Sheet" Jan. 31, p. 20). A new patient information leaflet has been developed, and a second "Dear Healthcare Professional" letter will be mailed at the beginning of the flu season in the fall

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