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U.S. Department of Health and Human Services

Safety

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Viread (Tenofovir Disoproxil Fumarate) Tablets and Powder

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Decreases in Bone Mineral Density
  • Assessment of bone mineral density (BMD) should be considered for adults and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss…
  • In clinical trials evaluating VIREAD in HIV-1 infected pediatric subjects 2 to less than 18 years of age, bone effects were similar to those observed in adult subjects…