PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS
Fatal and nonfatal pancreatitis has occurred during therapy with VIDEX used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. VIDEX should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis [see WARNINGS ANDPRECAUTIONS].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see WARNINGS AND PRECAUTIONS].
In January of this year the FDA announced its concern about the problems caused by this drug, discovered only from a review of adverse reaction reports in post marketing data.
FDA Revises HIV Drug Label for Liver Complication
By Cole Petrochko, Staff Writer, MedPage Today Published: January 31, 2010
WASHINGTON -- The FDA has updated labels of the HIV drug didanosine (Videx and Videx EC) to include warnings for potentially serious liver damage.
Although these cases are rare, the drug may cause noncirrhotic hypertension in patients, a potentially fatal complication which the FDA discovered through 42 postmarket, adverse event reports.
Of those patients, three required liver transplant and four died. Two deaths were caused by esophageal hemorrhage, while two more were caused by progressive liver failure.
One patient suffered multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis.
The FDA said in a statement that it chose not to recall the drug because it believes its benefits outweigh potential risks, but advised that treatment decisions be made on an individual basis between healthcare professionals and patients.
The agency added that causal association is difficult to determine in postmarket reports, but that alternative causes of the hypertension were ruled out in well-documented cases.
Healthcare professionals who determine didanosine is effective in treating a patient should monitor that patient for the development of portal hypertension and esophageal varices, the agency said.
Didanosine is used in combination with other HIV medications to help maintain CD4 cells in patients.
The drug already has a black box warning for lactic acidosis and hepatomegaly with steatosis.
Like the antiretroviral agents hydroxyurea and ribavirin, didanosine has been associated with the development of liver toxicity.