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U.S. Department of Health and Human Services

Safety

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Retrovir (zidovudine) capsules, tablets and syrup

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

 

November 2011

Summary View

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiationof treatment

 

November 2009

Summary View

 

PATIENT COUNSELING INFORMATION

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.