Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 14, Number 3/4, Spring 2000

Glaxo Wellcome has issued a warning about potential safety concerns with Agenerase (amprenavir) Oral Solution. The oral solution contains a significant amount of propylene glycol, which some people cannot metabolize sufficiently, leading to possible adverse events including seizures, stupor, lactic acidosis, rapid heart rate, kidney toxicity, and hemolysis (a loss of red blood cells). Because of this, Glaxo has changed the drug's package insert to include the following:

"Because of the potential risk of toxicity from the large amount of the excipient propylene glycol, Agenerase Oral Solution is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic or renal failure, and patients treated with disulfiram [Antabuse] or metronidazole [Flagyl]."

In general, Glaxo says, the oral solution should only be used when amprenavir capsules or other protease inhibitors are not a viable option. And if it is used, patients should be closely monitored for toxicities and should not use alcohol.

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