AEGiS-ATDN: Lactic Acidosis cases being reported by FDA

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

Lactic Acidosis cases being reported by FDA

Information Bulletin #15 - May 2002

Every anti-HIV drug can produce side effects. Although it is considered to be rare, a greater number of cases of a condition called Lactic Acidosis are being reported. The most commonly reported type of Lactic acidosis is coupled with severe hepatomegaly with steatosis (an enlarged fatty liver). Pancreatitis is also common. Lactic Acidosis is believed to be a rare but serious side effect of both nucleoside analog anti-HIV drugs, and the anti-HCV drug, Rebetol. Women, especially those who are overweight, are particularly at risk, but the condition has been reported to occur in men as well. Lactic acidosis probably results of mitochondrial toxicity. Mitochondria are the cell's power organs that supply the energy needed for normal cell growth. Anti-HIV and HCV drugs can impair the function of mitochondria. This can lead to increased acid levels in the blood, and an enlarged fatty liver.

The symptoms of lactic acidosis include feeling very weak, tired or uncomfortable; unusual or unexpected stomach discomfort; feeling cold; feeling dizzy or light-headed; difficulty breathing, or suddenly developing a slow or irregular heartbeat. People do recover from this condition, although it may take months depending on how severe the condition has become. If you are taken to an emergency room because of difficulty breathing or fatigue, you should be given oxygen as needed, and intravenous fluids until it is clear that you are stable. They will most likely check your heart as well. Although there is no approved treatment for this condition, timely emergency and hospital care can save lives. An arterial blood test of your lactate level can quickly determine if you have lactic acidosis.

The following letter from the FDA, and the letter from Bristol Myers Squibb demonstrate that even measuring lactate levels in the blood is not a definite way to diagnose the condition. Once Lactic Acidosis is diagnosed, it is usually very serious. Some doctors have tried vitamin B2 (riboflavin), as well as L-carnitine (or the prescribable drug called Carnitor) as treatment, with success. The federal government is currently developing studies of different techniques and potential treatments for the condition. Call 1-800-TRIALSA for more information about these studies or any studies in development.

Please refer to the Zerit label for full prescribing information. A copy of the revised labeling is available at: http://www.fda.gov/cder/foi/label/2002/20412S017.pdf. If you need help obtaining the letter contact your network case manager or e-mail us with a request at network@atdn.org

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