Videx®

Fatal lactic acidosis has recently been reported in pregnant women treated throughout gestation with the combination of stavudine (Zerit®) and didanosine (Videx®). Lactic acidosis occurs when cells of the body are unable to convert food into usable energy. As a result, excess acid accumulates in the body and vital organs such as the liver or pancreas may be damaged. Severe lactic acidosis is an infrequent, but well-described complication of the class of HIV drugs known as nucleoside analogues. Pancreatitis is also a well-described complication of Videx® and Zerit®.

Two treatment-naive patients died of pancreatitis approximately seven months after initiation of treatment with didanosine plus stavudine and protease inhibitor in two clinical trials.

Two deaths due to pancreatitis occurred among 68 previously treated patients enrolled in an arm of the ACTG 5025 study which utilized didanosine with hydroxyurea (600 mg BID) plus stavudine and indinavir. Both patients were hospitalized for pancreatitis within three months of enrollment and died one to ten weeks after diagnosis. Although a formal causal relationship was not established, the ACTG 5025 trial was subsequently terminated due to the higher risk of several toxicities, including fatal and non-fatal pancreatitis, in this treatment group.

In addition, deaths due to pancreatitis in patients treated with didanosine have been reported to the FDA MedWatch program. Since 1998, the majority of these reports have been in patients who were also receiving stavudine with and without hydroxyurea.

Source: fda.gov

If you or a loved one has been harmed by Videx®, you may want to contact a Videx® attorney for more information.