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Label Changes for:

Retrovir (zidovudine) capsules, tablets

November 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009


Information About Therapy With Retrovir
  • Lactic Acidosis/Hepatomegaly: Patients should be informed that some HIV medicines, including Retrovir, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly).
  • HIV-1/HCV Co-Infection: Patients with HIV-1/HCV co-infection should be informed that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.