HIV Drug Didanosine Potentially Causes Fatal Liver Disease

Adding insult to injury, the Food and Drug Administration recently stated that one of the oldest drugs used to treat the AIDS virus has been found to produce rare cases of a potentially fatal liver disease. The drug, Didanosine, was approved in 1991 as the second drug approved for the treatment of HIV infections. The drug has been marketed over the years as Videx and Videx EC, and is manufactured by Bristol-Myers Squibb. It works by preventing a key enzyme used by HIV in replication. Additionally, the drug does little to combat the spread of HIV because the virus mutates so quickly, and is therefore usually used in a drug combination regimen.

The Food and Drug Administration was prompted to issue a warning due to several individuals (over the eighteen years since it has been in use) who report suffering from a rare condition called non-cirrhotic portal hypertension. This occurs when severe high blood pressure in the portal vein, which is a primary vein in the liver, causes the vein to enlarge and deteriorate. Because the vein has weakened, it then rips open, leading to fatal bleeding. This type of liver disease is not caused by alcohol abuse or by Hepatitis B, rather from the drug’s interaction with the flow of blood through the body.

Of all of the known forty- two cases of the rare disease, twenty-six were males, fourteen were females, and two did not report gender. Additionally, the disease affected individuals of all age groups, ranging from ten to sixty-six years of age. Most importantly, the patients had been taking the drug for a number of months or years before the liver disease presented itself. The disease, however, was discovered to be very damaging and in some cases fatal. Four individuals died from bleeding or organ failure, while eight had surgical interventions to strengthen the vein or endured liver transplants. Of those eight, only the three patients who had the liver transplants fully recovered from the disease.

Despite these dire circumstances once the disease develops, the Food and Drug Administration concluded that the benefits of the drug outweigh the risks. As such, it will strengthen the warning so that medical personnel and patients are aware that a possible problem may develop. If you have taken this drug for any length of time, however, you should ask your doctor about any tests that may be used to rule out liver disease. Additionally, if you already have liver disease and are taking this medication, it is important that you ask your physician if another drug may be used.