US FDA warns on liver disorder associated with the use of Bristol-Myers Squibb's Videx

The US Food and Drug Administration last Friday alerted health care professionals and patients about a rare, but serious, liver complication non-cirrhotic portal hypertension, in patients using US drug major Bristol-Myers Squibb's HIV drug Videx (didanosine) or the delayed-release formulation Videx EC.

The FDA said it became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to its Adverse Event Reporting System (AERS). Based on these reports, the agency has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this product. Data showed that among the 42 reports there were four deaths, which resulted from liver failure or hemorrhaging.

Bristol-Myers spokesman Brian Henry said the company has updated its label for the drug, which generated worldwide sales of $71 million in 2009.