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U.S. Department of Health and Human Services

Safety

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Fosamax (alendronate sodium) tablets and oral solution

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

 

Summary View

 

PRECAUTIONS

  • For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

ADVERSE REACTIONS

Post-Marketing Experience
  • Musculoskeletal: “low-energy femoral shaft and subtrochanteric fractures

PATIENT INFORMATION

What are the possible side effects of Fosamax? 
  • 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.
  • may cause jaw-bone problems in some people. Jaw-bone problems may include infection, and delayed healing after teeth are pulled.
What should I tell my doctor before using Fosamax?
  • include dental condition