AEGiS-ATDN: New Warning About Abacavir (Ziagen)

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

New Warning About Abacavir (Ziagen)

Information Bulletin #12 August/September 2000

Hypersensitivity (allergic) reactions to the NRTI drug abacavir (trade name Ziagen) were reported in approximately 3-5#37; of the people that participated in clinical trials. Symptoms of abacavir hypersensitivity are a general sick feeling, low grade fever and nausea, with or without vomiting. There can also be symptoms that affect breathing, such as shortness of breath, cough and sore throat. In some people in studies, a rash appeared 1-3 days after onset of the first symptoms.

Several clinical trial participants who tried to restart abacavir after having a hypersensitivity reaction developed severe symptoms within hours and had to be hospitalized. At least two people died. This led to a warning that abacavir should be stopped and not restarted if a hypersensitivity reaction was suspected.

It has now been reported that some people have experienced potentially fatal symptoms after a temporary interruption of abacavir treatment, even though they did not stop the drug because of a hypersensitivity reaction. In these reports, people interrupted treatment with abacavir for other reasons and were not having problems with abacavir when they stopped.

When they restarted the drug, they developed the same life-threatening symptoms as those seen in the clinical trial participants who stopped due to an allergic reaction. Several people are thought to have died as a result. A new warning has now been issued. The warning says that restarting abacavir after an interruption should be done with extreme caution and only when emergency medical care is easily accessible. Since it's uncertain how long an interruption might be a problem, it's probably a good idea to be careful about restarting abacavir if you've stopped for more than a day or two.

The full text of the Ziagen warning letter can be downloaded from the Internet at: http://www.fda.gov/medwatch/safety/2000/safety00.htm#ziagen
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