What are the contraindications for using Fosamax (alendronate)?

Contraindications to Fosamax (Alendronate)

Fosamax (alendronate) is absolutely contraindicated in patients with inability to stand or sit upright for at least 30 minutes, hypocalcemia, and hypersensitivity to any component of the product. 1

Absolute Contraindications

1. Inability to remain upright for at least 30 minutes after taking the medication

   • This is critical to prevent esophageal irritation and potential esophagitis 1, 2
   • Patients must be able to sit or stand upright after taking the medication to ensure proper transit to the stomach

2. Hypocalcemia

   • Untreated low calcium levels must be corrected before starting alendronate 1
   • Bisphosphonates can further decrease calcium levels in patients with pre-existing hypocalcemia

3. Hypersensitivity to alendronate or any component of the formulation

   • Reported hypersensitivity reactions include urticaria and angioedema 1

Relative Contraindications and Precautions

1. Severe renal impairment

   • Not recommended in patients with creatinine clearance < 35 mL/min/1.73 m² 3
   • Renal function should be monitored in patients with compromised kidney function

2. Active upper gastrointestinal problems

   • Esophageal disorders that delay esophageal emptying (e.g., stricture, achalasia)
   • History of esophageal disease
   • Active gastric or duodenal ulcers 2

3. Vitamin D deficiency

   • Should be corrected before initiating therapy to prevent hypocalcemia
   • Target serum 25(OH)D levels should be ≥30 ng/mL 3, 4

4. Pregnancy and lactation

   • Bisphosphonates are not recommended during pregnancy or breastfeeding

5. Planned invasive dental procedures

   • Consider completing necessary dental work before initiating therapy to minimize risk of osteonecrosis of the jaw 4

Administration Requirements

Proper administration is crucial to minimize adverse effects:

• Must be taken with a full glass of water (180-240 mL or 6-8 oz) 2
• Must be taken first thing in the morning, at least 30 minutes before the first food, beverage, or other medication of the day 2, 5
• Patient must remain upright (sitting or standing) for at least 30 minutes after taking the medication 1, 2

Common Adverse Effects to Monitor

• Upper GI tract issues: abdominal pain, dyspepsia, acid regurgitation, nausea 6
• Esophageal irritation and esophagitis (can be severe in some cases) 2
• Musculoskeletal pain 6

Clinical Pearls

• Weekly dosing (70 mg once weekly) is therapeutically equivalent to daily dosing (10 mg daily) and may improve adherence 7
• Calcium and vitamin D supplementation should be optimized when starting alendronate 3, 4
• Patients should be instructed to discontinue the medication and seek medical attention if they develop symptoms of esophageal irritation (dysphagia, retrosternal pain, new/worsening heartburn) 2
• Alendronate is effective for both male and female osteoporosis 6, 8

Understanding these contraindications and proper administration requirements is essential for safe and effective use of alendronate in the treatment of osteoporosis.