Label Changes for:

Fosamax Plus D (Alendronate Sodium/Cholecalciferol) Tablets

November 2013

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

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

 

 

November 2013

ADVERSE REACTIONS

Clinical Trials Experience
  • The safety of FOSAMAX in the treatment of postmenopausal osteoporosis was assessed in four clinical trials that enrolled 7453 women aged 44-84 years….

USE IN SPECIFIC POPULATIONS

Pregnancy
  • There are no studies in pregnant women. FOSAMAX PLUS D should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus…
Renal Impairment
  • FOSAMAX PLUS D is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35-60 mL/min.
Hepatic Impairment
  • Alendronate Sodium - As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary…

 

 

March 2010

 

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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