When Not to Use Fosamax (Alendronate)
Fosamax is absolutely contraindicated in patients with esophageal abnormalities that delay esophageal emptying, inability to stand or sit upright for at least 30 minutes, uncorrected hypocalcemia, and hypersensitivity to any component of the product. 1, 2
Absolute Contraindications
The following conditions represent absolute contraindications where Fosamax should never be prescribed:
- Esophageal abnormalities including achalasia, strictures, or any condition that delays esophageal emptying 1, 2
- Inability to stand or sit upright for at least 30 minutes after taking the medication, as this dramatically increases esophageal injury risk 1, 2
- Uncorrected hypocalcemia - calcium levels must be normalized before initiating therapy 1, 2
- Known hypersensitivity to alendronate or any component of the formulation 1, 2
- Increased risk of aspiration due to the severe consequences of medication entering the airway 1
Critical Relative Contraindications Requiring Extreme Caution
Renal Impairment
- Avoid oral alendronate in patients with creatinine clearance <30-35 mL/min due to accumulation risk and increased adverse effects 1
- Intravenous bisphosphonates should not be used when creatinine clearance is below 30 mL/min 1
Active Upper Gastrointestinal Disorders
- Do not use in patients with active esophagitis, gastritis, or peptic ulcer disease until these conditions are resolved 2, 3, 4
- Patients with dysphagia or swallowing difficulties are at markedly increased risk for severe esophageal complications 3, 5
- History of Barrett's esophagus or other preexisting esophageal pathology warrants extreme caution 6
Common pitfall: Even when patients receive detailed instructions on proper administration, elderly or handicapped patients with any history of swallowing problems remain at high risk for severe esophageal injury, including ulceration, stricture formation, and hemorrhage. 3, 4, 7
Vitamin D Deficiency
- Correct vitamin D deficiency before initiating bisphosphonate therapy to prevent severe hypocalcemia, particularly with IV formulations 1
- Failure to address this can result in symptomatic hypocalcemia with muscle spasms, tetany, and cardiac complications 2, 8
Recent or Planned Dental Procedures
- Consider delaying alendronate initiation in patients who have recently undergone dental extractions or oral surgery due to osteonecrosis of the jaw (ONJ) risk 1
- Baseline dental examination is mandatory before starting therapy 9, 2
- Patients requiring extensive dental work should complete procedures before bisphosphonate initiation when possible 1
High-Risk Clinical Scenarios Requiring Alternative Therapy
Concurrent Medications
- Patients taking NSAIDs or aspirin chronically have compounded gastrointestinal toxicity risk and may benefit from alternative osteoporosis therapies 2, 4
- Those on corticosteroids require careful monitoring but are not absolutely contraindicated 2
Malabsorption Syndromes
- Patients with documented malabsorption (celiac disease, inflammatory bowel disease) may not achieve therapeutic benefit and face increased adverse effect risk 2
Pregnancy and Lactation
- Alendronate is contraindicated in pregnancy due to unknown fetal effects on skeletal development 2
- Avoid in breastfeeding mothers as drug passage into breast milk is unknown 2
Key clinical consideration: The FDA label emphasizes that esophageal problems (irritation, inflammation, ulcers, bleeding) represent the most serious common adverse effect, with symptoms including chest pain, new or worsening heartburn, or difficulty/pain with swallowing requiring immediate discontinuation. 2 These complications can occur even with perfect adherence to administration instructions, particularly in patients over 70 years old. 3, 7