FDA Liver Risk Warning for Bristol-Myers HIV Drug

WASHINGTON (AP) -- Federal health officials say patients taking a Bristol-Myers Squibb drug for HIV have reported a rare, but potentially fatal liver disorder.

The Food and Drug Administration says it received 42 reports of the disorder since Videx was approved in 1991. Four patients died from bleeding or liver failure after developing the problem, known as non-cirrhotic portal hypertension.

The problem involves dangerously slow blood flow though the liver, which can cause veins in the esophagus to swell. These veins are thin and can cause burst, causing potentially deadly bleeding.

FDA says it is keeping the drug on the market because its benefits outweigh its risks. The agency added warnings to the drug's label about the signs of the liver disorder.


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