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[AEGiS] CATIE News: Abacavir warning revised

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Mary Elizabeth

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Jan 28, 2000, 3:00:00 AM1/28/00
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Glaxo Wellcome has issued a revised warning about its drug abacavir
(Ziagen), a nucleoside reverse transcriptase inhibitor that was licensed
for sale in Canada in June 1999. The warning concerns a serious
hypersensitivity reaction to abacavir that has been documented in about
three to six per cent of users. Previous warnings have listed the common
symptoms of a hypersensitivity reaction as fever, rash, fatigue and
gastrointestinal problems such as nausea, diarrhea and vomiting. These
symptoms generally occur within the first few weeks of therapy. When such
reactions occur, abacavir must be stopped immediately and never restarted,
otherwise a more severe reaction may occur, including a potentially fatal
drop in blood pressure.

Glaxo has issued this revised warning in light of recent information that
suggests respiratory symptoms play a larger role than previously thought in
hypersensitivity reactions to abacavir. In fact, a number of deaths have
been reported due to reactions characterized by dyspnea (difficulty
breathing), cough and pharyngitis (sore throat). In some cases, the deaths
occurred in patients in whom a hypersensitivity reaction involving
respiratory symptoms was misdiagnosed as an acute respiratory illness such
as pneumonia or bronchitis. According to Glaxo Wellcome, respiratory
symptoms have occurred in about 20 per cent of patients who have had
hypersensitivity reactions to abacavir.

In light of this information, doctors should seriously consider the
possibility of a hypersensitivity reaction to abacavir in their patients
who present with symptoms of acute respiratory diseases. For more
information, health-care professionals can call Glaxo Wellcome's Medical
Information Department at 1-800-668-6051. Physicians are also encouraged to
report any cases of hypersensitivity reaction to the Canadian Ziagen
Support Line at 1-800-868-8898.


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