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U.S. Department of Health and Human Services

Safety

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Aromasin (exemestane) tablets

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

 

May 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.3 Reductions in Bone Mineral Density (BMD)
  • risk of osteoporosis added

6 ADVERSE REACTIONS

6.2 Post-Marketing Experiences
  • ...include hypersensitivity, paresthesia, cholestatic hepatitis, and acute generalized exanthematous pustulosis, urticaria, and pruritus. 

 

February 2013

Summary View 

WARNINGS AND PRECAUTIONS

Vitamin D Assessment
  • Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed, due to the high prevalence of vitamin D deficiency in women with early breast cancer (EBC). Women with vitamin D deficiency should receive supplementation with vitamin D.
 

ADVERSE REACTIONS

Postmarketing Experience
  • hypersensitivity
  • urticaria
  • pruritis

 

March 2011 

Summary View 

ADVERSE REACTION

  • adverse event information to the labeling based on 52 months of median follow-up in study 96-OEXE 031
Post-Marketing Experience
  • addition of information cholestatic hepatitis