Label Changes for:

Aredia (pamidronate disodium) for Injection

May 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

May 2012 

WARNINGS

Pregnancy: 
  • Bisphosphonates, such as Aredia, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. Aredia may cause fetal harm when administered to a pregnant woman. In reproductive studies in rats and rabbits ....

PRECAUTIONS

Laboratory Tests
  • .... Patients receiving Aredia may be at risk for anemia, leukopenia or thrombocytopenia and should have regular hematology assessments.
Pregnancy Category D (See WARNINGS)
  • There are no adequate and well-controlled studies in pregnant women. Aredia may cause fetal harm when administered to a pregnant woman. Bisphosphonates, such as Aredia, are incorporated .....
Nursing Mothers
  • It is not known whether pamidronate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Aredia, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Atypical fractures of the femur
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy, including Aredia. These fractures can occur anywhere in the femoral shaft from ..... Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. A number of case reports noted that patients were also receiving treatment with glucocorticoids .....
  • Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain in the absence of trauma should be suspected ..... 

ADVERSE REACTIONS

Post-Marketing Experience
  • The following adverse reactions have been reported during post-approval use of Aredia. Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Renal and urinary disorders: renal tubular disorders (RTD); tubulointerstitial nephritis, and glomerulonephropathies. 
  • Respiratory, thoracic and mediastinal disorders: adult respiratory distress syndrome (ARDS), interstitial lung disease (ILD).  
  • Musculoskeletal and connective tissue disorders: severe and occasionally incapacitating bone, joint, and/or muscle pain
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, including Aredia. (See PRECAUTIONS.)

 

April 2011

 

ADVERSE REACTIONS

Postmarketing Experience
  • ...Special Senses: orbital inflammation...

 

March 2011

 

ADVERSE REACTIONS

Post-Marketing Experience
  • Special senses: orbital inflammation 

 

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