What are the considerations for a patient taking Fosamax (alendronate) and what are the potential adverse effects to watch for?

From the Guidelines

Patients taking Fosamax (alendronate) should be closely monitored for potential side effects, including mild upper GI symptoms, atypical subtrochanteric fracture, and osteonecrosis of the jaw, as highlighted in the American College of Physicians guideline update 1. When taking Fosamax, patients should follow specific administration instructions to minimize the risk of adverse effects. They should take the medication first thing in the morning with a full glass of plain water, at least 30 minutes before consuming any food, beverages, or other medications. Additionally, they must remain upright (sitting or standing) for at least 30 minutes after taking it to prevent the medication from irritating the esophagus 1.

Common side effects to watch for include:

• Stomach pain
• Nausea
• Heartburn
• Muscle or joint pain More serious concerns include:
• Severe chest pain
• Difficulty swallowing
• New or worsening heartburn
• Painful or swollen gums Patients should also be aware of rare but serious side effects such as osteonecrosis of the jaw (particularly after dental procedures) and atypical femur fractures 1.

Regular dental check-ups are important while on this medication, and patients should have any necessary dental work completed before starting Fosamax 1. Adequate calcium and vitamin D intake should be maintained during treatment, but calcium supplements should be taken at a different time of day than Fosamax. The medication works by inhibiting bone breakdown, helping to maintain or increase bone density and reduce fracture risk in osteoporosis patients. Patients should report any new thigh or groin pain, as this could indicate a rare femur fracture, and should discuss with their doctor how long they should remain on the medication, as benefits and risks change with long-term use 1.

From the FDA Drug Label

1. 1 Upper Gastrointestinal Adverse Reactions Alendronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when alendronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers)

2. 2 Mineral Metabolism Hypocalcemia must be corrected before initiating therapy with alendronate sodium [see Contraindications (4)].

3. 3 Musculoskeletal Pain In post-marketing 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 [see Adverse Reactions (6. 2)].

Considerations for Patients Taking Fosamax:

• Upper Gastrointestinal Adverse Reactions: Patients should be cautious when taking alendronate sodium, especially those with active upper gastrointestinal problems.
• Mineral Metabolism: Hypocalcemia must be corrected before initiating therapy with alendronate sodium.
• Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.
• Patients should be instructed to discontinue alendronate sodium and seek medical attention if they develop:
  • Dysphagia
  • Odynophagia
  • Retrosternal pain
  • New or worsening heartburn 2

From the Research

Considerations for Patients Taking Fosamax

• Patients taking Fosamax (alendronate) should be aware of the risk of osteonecrosis of the jaw (ONJ), a rare but potentially serious condition characterized by exposed bone in the maxillofacial area 3, 4, 5, 6.
• The risk of ONJ is higher in patients receiving high-dose intravenous bisphosphonates for malignant diseases, but it can also occur in patients taking oral bisphosphonates for osteoporosis, although the risk is lower 3, 4.
• Factors that increase the risk of ONJ include:
  • Recent or long-term use of alendronate 4, 6
  • High adherence to alendronate treatment 4
  • History of rheumatoid disorders 4
  • Use of proton pump inhibitors 4
  • Advanced age 6
  • Coexisting diabetes and rheumatoid arthritis 6
• Patients should inform their dentist about their Fosamax treatment before undergoing any dental procedures, and dental procedures should be completed before initiating high-dose intravenous bisphosphonate therapy for cancer 3.
• Good dental hygiene is essential for all patients taking Fosamax, and patients should be informed of the low risk of ONJ 3.

Things to Watch For

• Patients taking Fosamax should be monitored for signs and symptoms of ONJ, including:
  • Exposed bone in the maxillofacial area
  • Pain or swelling in the jaw or mouth
  • Loose teeth or dentures
  • Difficulty swallowing or speaking
• Patients who develop ONJ should receive conservative treatment, including antimicrobial mouthwash, antibiotics for secondary infection, and limited debridement 3.
• The prognosis of ONJ can be improved with early discovery of lesions and prevention of their deeper extension, and serum bone-specific alkaline phosphatase (BSAP) level can be a useful marker for predicting the prognosis of ONJ 7.