FDA reviews MI risk in Videx, Ziagen users

The FDA is reviewing study results linking recent treatment with Ziagen (abacavir, from GlaxoSmithKline) or Videx (didanosine, from Bristol-Myers Squibb) to an increased risk of myocardial infarction (MI). The D:A:D Study involving 33,347 HIV-1 infected patients revealed that patients taking Ziagen or Videx had a greater chance of developing an MI than patients taking other medications. The risk did not appear to increase over time, but remained stable and appeared to be reversible after Ziagen or Videx were stopped.

The FDA believes the study analysis is incomplete, but will continue to evaluate the overall risks and benefits of Ziagen and Videx.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110619.htm.