The FDA has issued a warning about an association between use of ddI (didanosine) and the development of non-cirrhotic portal hypertension:
Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (the portal vein) slows down.
–snip–
Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication.
Yes, this is a bad one — of the 42 reported cases, 4 patients died; several others required aggressive interventions to reduce the risk of variceal bleeding, including banding/ligation of esophageal varices, transjugular intrahepatic portosystemic shunts (TIPPS), and liver transplantation.
ddI was our second approved antiretroviral, way back in 1991.
Over the years, it has improved — we’ve reduced the dose, now can give it once daily, and have gotten rid of the original bizarre formulation (pictured).
And while it does have reasonable antiviral potency (at least for an NRTI), its myriad potentially severe side effects — neuropathy, pancreatitis, lactic acidosis, to name a few — and the availability of numerous other options mean that there is little reason for a person to be receiving it today.