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U.S. Department of Health and Human Services

Safety

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Fosamax Plus D (alendronate sodium/cholecalciferol) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

 

Summary View

 

WARNINGS

Osteonecrosis of the Jaw
  • Revision of Section
Upper Gastrointestinal Adverse Reactions
  • Minor revision of subsection

ADVERSE REACTIONS

Post-Marketing Experience
  • Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported rarely
  • Musculoskeletal: low-energy femoral shaft and subtrochanteric fractures

PATIENT INFORMATION

What should I tell my doctor before using Fosamax Plus D?
  • include dental conditions
What are the possible side effects of Fosamax Plus D?
  • Some patients have experienced fracture in a specific part of the thigh bone. Call your doctor if you develop new or unusual pain in the hip or thigh.

 

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