Can a patient with melena (black tarry stools) and gastric diverticulum take Fosamax (alendronate)?

Fosamax Should Not Be Used in This Patient

A patient with melena (black tarry stools) and gastric diverticulum should not take Fosamax (alendronate) due to the high risk of severe gastrointestinal complications, including ulceration, perforation, and bleeding in the setting of pre-existing upper GI pathology.

Critical Contraindications Present

Active Upper GI Bleeding

• The FDA drug label explicitly states that alendronate "may cause local irritation of the upper gastrointestinal mucosa" and that "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)" 1
• Melena indicates active upper GI bleeding, which represents an absolute contraindication to initiating bisphosphonate therapy 1
• The source of bleeding must be identified and treated before considering any ulcerogenic medications 1

Gastric Diverticulum as Structural Abnormality

• Alendronate tablets can become entrapped within diverticula, leading to intense acute inflammatory changes, severe ulceration, and even perforation 2
• A case report documented severe diverticulitis in a Zenker's diverticulum secondary to alendronate, with the tablet causing caustic injury when trapped 2
• Another case demonstrated perforation of gastric volvulus within a giant hiatus hernia secondary to an alendronate tablet found in the mediastinum, illustrating the devastating consequences of bisphosphonate use in patients with structural GI abnormalities 3
• Bisphosphonates should be administered with extreme caution or avoided entirely in patients with known structural abnormalities of the upper GI tract 2

Evidence of Direct Gastric Injury

Ulcerogenic Potential

• Clinical trials demonstrated that alendronate 10 mg daily (the standard osteoporosis dose) caused gastric ulcers in 2 of 24 healthy volunteers (8%) and large erosions in 4 additional subjects (17%), compared to zero ulcers in placebo recipients 4
• Post-marketing surveillance identified gastric and duodenal ulcers, some severe with complications, though no increased risk was observed in controlled trials 1
• The FDA label specifically warns about gastric and duodenal ulcers as post-marketing adverse events 1

Esophageal Complications

• Severe esophagitis, esophageal ulcers, erosions, and rarely esophageal stricture or perforation have been reported, with some cases requiring hospitalization 1, 5
• Of 199 patients with esophageal adverse effects reported to the manufacturer, 51 (26%) had serious or severe complications, and 32 (16%) required hospitalization 5

Clinical Management Algorithm

Immediate Actions Required

1. Discontinue any consideration of Fosamax - The combination of active GI bleeding and structural abnormality represents an absolute contraindication 1, 2
2. Investigate the source of melena - Perform upper endoscopy to identify bleeding source, assess the gastric diverticulum, and rule out malignancy 1
3. Treat the underlying bleeding - Address the cause of melena before considering any bone-protective therapy 1

Alternative Osteoporosis Management

• Consider intravenous bisphosphonates (zoledronic acid) once GI bleeding is resolved and healed, as these bypass the upper GI tract entirely 6
• Evaluate for denosumab (subcutaneous injection) as an alternative that avoids GI exposure 6
• Consider selective estrogen receptor modulators (SERMs) or other non-bisphosphonate options depending on fracture risk and contraindications 6

Critical Pitfalls to Avoid

• Never prescribe oral bisphosphonates to patients with active upper GI symptoms - The FDA label explicitly warns against this practice 1
• Do not assume the gastric diverticulum is incidental - Structural abnormalities significantly increase the risk of tablet entrapment and caustic injury 2, 3
• Do not restart alendronate after GI symptoms resolve if structural abnormalities persist - The gastric diverticulum remains a permanent contraindication to oral bisphosphonates 2, 3
• Recognize that even the 10 mg osteoporosis dose causes significant gastric injury - This is not limited to the higher 40 mg Paget's disease dose 4