×
Min. Age:
Max. Age:
Gender:
Reason:
Duration:

Fosamax

Generic Name: Alendronate Sodium
Drug Category: Bisphosphonate
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 4 years.

Approved Uses

Indicated for:

Treatment of Osteoporosis in Postmenopausal Women:

• The treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).

Prevention of Osteoporosis in Postmenopausal Women:

• The prevention of postmenopausal osteoporosis.

Treatment to Increase Bone Mass in Men with Osteoporosis:

• Treatment to increase bone mass in men with osteoporosis.

Treatment of Glucocorticoid-Induced Osteoporosis:

• The treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density.

Treatment of Paget’s Disease of Bone:

• The treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including FOSAMAX. In some cases these have been severe and required hospitalization.

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.

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including FOSAMAX. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures).

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

FOSAMAX is not recommended for patients with creatinine clearance less than 35 mL/min.

FOSAMAX is contraindicated in patients with:

  • Abnormalities of the esophagus which delay emptying such as stricture or achalasia
  • Inability to stand/sit upright for at least 30 minutes
  • At increased risk of aspiration
  • Hypocalcemia

Hypocalcemia must be corrected before initiating therapy with FOSAMAX. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated.

Co-administration of FOSAMAX and calcium, antacids will interfere with absorption of FOSAMAX.

Upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of FOSAMAX greater than 10 mg and aspirin-containing products.

There are no studies in pregnant women. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. Discontinue FOSAMAX when pregnancy is recognized. Animal studies: decreased postimplantation survival, decreased body weight, and fetal death.

It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FOSAMAX is administered to nursing women.

GoToSource

Off-label Uses

• Cancer-associated hypercalcemia. GoToSource

• Cancers that have metastasized to the bone. GoToSource

• Osteoporosis in premenopausal women. GoToSource

• Use in patients under the age of 18. GoToSource

• Adjunctive therapy in patients with gaucher disease previously treated with enzyme replacement therapy. GoToSource

• Polyostotic fibrous dysplasia. GoToSource

• Antipsychotic-related osteopenia. GoToSource

• Duchenne muscular dystrophy. GoToSource

• Children with osteogenesis imperfecta. GoToSource

• Renal lithiasis. GoToSource

• Alveolar bone loss in periodontitis. GoToSource

• Prevention of skeletal metastases in men with prostate cancer. GoToSource

Adverse Events

Severe bone, joint or muscle pain. GoToSource

Increased risk of atrial fibrillation. GoToSource

Oesophageal cancer. GoToSource

Esophagitis, esophageal ulcers, esophageal perforation and gastroduodenal ulcers. GoToSource

Osteonecrosis of the jaw. GoToSource

Pelvic fractures. GoToSource

Atypical fractures of the thigh. GoToSource

Liver damage. GoToSource

Kidney damage. GoToSource 

Secondary hyperparathyroidism (excess parathyroid hormone). GoToSource

Intraocular inflammation. GoToSource 

Cholesteatoma of the external auditory canal. GoToSource

Litigation

Lawsuits filed for osteonecrosis of the jaw, femur fractures, osteomyelitis, esophageal ulceration and cancer. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

 iOSAndroidAppOrchard - EPIC EHR

Site Last Updated March 28, 2024