Alendronate Contraindications
Alendronate is absolutely contraindicated in patients who cannot stand or sit upright for at least 30 minutes, those with esophageal abnormalities, hypocalcemia, and hypersensitivity to any component of the product. 1
Absolute Contraindications
The FDA drug label and clinical guidelines establish the following absolute contraindications 2, 1:
Inability to stand or sit upright for at least 30 minutes - This is critical because the medication must transit through the esophagus quickly to minimize mucosal contact and reduce risk of severe esophagitis 1, 3
Esophageal abnormalities - Including achalasia, strictures, or any condition that delays esophageal emptying, as these dramatically increase the risk of pill esophagitis and ulceration 4, 2, 1
Hypocalcemia - Must be corrected before initiating therapy, as bisphosphonates can worsen hypocalcemia and this risk is particularly pronounced with intravenous formulations 4, 2, 1
Hypersensitivity to alendronate or any component - Including documented urticaria or angioedema reactions 1
Increased risk of aspiration - Patients at high aspiration risk should not receive oral alendronate 2
Relative Contraindications and Important Precautions
Renal Impairment
- Creatinine clearance <30 mL/min - Intravenous bisphosphonates should be avoided due to risk of acute renal failure and increased serum creatinine 4, 2, 5
- Oral alendronate requires caution in renal impairment, though it appears to have better renal safety than IV formulations 4
Recent Dental Procedures
- Recent dental surgery or extractions - Consider delaying alendronate initiation until healing is complete, as this is the most consistent risk factor for osteonecrosis of the jaw 4, 2, 5
- Dental examination and completion of necessary dental work should occur before starting therapy 4
Vitamin D Deficiency
- Uncorrected vitamin D deficiency - Must be corrected before initiating bisphosphonates to prevent hypocalcemia and optimize efficacy 4, 2, 5
- Target 25(OH)D levels >32 ng/mL, with some experts recommending 40-50 ng/mL 4
Critical Administration Requirements to Avoid Complications
The following are not contraindications per se, but failure to follow these instructions creates conditions that effectively contraindicate safe use 3, 6:
- Must be taken with at least 6-8 oz (180-240 mL) of plain water 3, 6
- Must be taken on an empty stomach, first thing in the morning 4, 6
- Patient must remain upright for at least 30 minutes after administration and until first food is consumed 4, 1, 3
- No food, drink, or other medications for at least 30 minutes after dosing 4
Common Pitfalls
Esophagitis cases reported in postmarketing surveillance were strongly associated with patients who 3:
- Swallowed tablets with little or no water
- Lay down during or immediately after ingestion
- Continued taking alendronate after onset of esophageal symptoms
- Had preexisting esophageal disorders
Discontinue alendronate immediately if esophageal symptoms develop (dysphagia, odynophagia, retrosternal pain) 3.