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Treatment Briefs: Changes in Warning on Abacavir Hypersensitivity

Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 13, Number 11/12, November/December 1999
Gil Shepard

Since its approval, abacavir (Ziagen), a nucleoside analog, has been known to cause a severe hypersensitivity reaction in three to five percent of people who take it. Recently, Glaxo Wellcome has revised the drug's warning label to emphasize the role of respiratory symptoms in this hypersensitivity reaction. Different patients can exhibit very different symptoms of hypersensitivity, including fever, rash, gastrointestinal symptoms, fatigue and malaise. Now, Glaxo Wellcome has reported that about 20% of patients with a hypersensitivity reaction have respiratory symptoms, such as cough, dyspnea (difficulty in breathing; shortness of breath) and pharyngitis (inflammation of the pharynx); in contrast, wheezing and bronchospasm are not very frequent. Deaths resulted because some patients were misdiagnosed as having pneumonia, bronchitis or a flu-like illness. Due to the life-threatening nature of abacavir hypersensitivity, it is crucial that patients having a reaction discontinue abacavir. Moreover, anyone who has had a hypersensitive reaction to abacavir should never restart the drug since more severe symptoms will occur within hours, possibly leading to death.

Is it possible to avoid the abacavir hypersensitivity reaction altogether? Glaxo is currently trying to find out with a desensitization study, in which abacavir will be given in incremental doses over one week.

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