FOSAMAX Patient Product Information

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Patient Product Information
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Important Information About FOSAMAX® (alendronate sodium) and FOSAMAX PLUS D

FOSAMAX and FOSAMAX PLUS D are contraindicated in patients with esophageal abnormalities which delay esophageal emptying (eg, stricture or achalasia) and in patients unable to stand or sit upright for at least 30 minutes. Patients at increased risk of aspiration should not receive FOSAMAX oral solution. FOSAMAX and FOSAMAX PLUS D are contraindicated in patients with hypocalcemia (see WARNINGS AND PRECAUTIONS) and in patients with hypersensitivity to any component of these products. Hypersensitivity reactions including urticaria and angioedema have been reported. FOSAMAX and FOSAMAX PLUS D, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa.

In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping treatment.

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates.

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