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Pharmaceutical giant Bristol-Myers Squibb has been forced to amend the labelling of one of its HIV drug treatments following a number of reports of patients suffering from a rare, but sometimes fatal, liver disorder.
According to health officials in the US, Videx has been linked to 42 cases of non-cirrhotic portal hypertension since 1991, which results in potentially fatal bleeding in the oesophagus caused by slow blood flow through the liver.
Videx, which is used as part of a combination of anti-viral treatments to halt the development of HIV, will remain in use but with revised instructions for patients after the Food and Drug Administration (FDA) deemed its benefits to outweigh the new risks posed to patients’ health.
The agency added warnings to the drug’s label about the signs and symptoms of the liver disorder. According to the new labelling, patients “should be monitored for early signs of portal hypertension during routine medical visits.”
New York-based Bristol Myers Squibb said in a statement: “As with all our medicines, we work closely with the FDA to monitor safety events.”
