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Fosamax Side Effects and History

By Pam Flores, Health Guide Saturday, August 27, 2011

Fosamax® (alendronate sodium) is one of the bisphosphonates used to treat osteoporosis, and it's been in use since 1995.  Since this drug has been on the market the longest, we have more long-term data on its precautions and warnings.

 

Many of our members ask questions about this drug so we wanted to explain its risks and benefits.

 

Fosamax Side Effects

 

Abdominal pain

Diarrhea

Vomiting

Nausea

Flatulence

Dysphagia

Dyspepsia

Acid regurgitation

Abdominal distention

Constipation

Esophageal ulcer

Gastritis

Musculoskeletal pain

Dizziness

Melena

Muscle cramp

Taste perversion

(Rarely) uveitis

Headache

Gastroesophgeal reflux

(Rarely) scleritis    [1]

 

 

Adverse side effects above were reported in ≥ 1% of patients treated with Fosamax [1]

 

Pre-administration tests and conditions

  

Fosamax is not recommended in patients who have kidney disease or a creatinine clearance test of ˂ 35 mL/min.  Hypocalcemia (low blood calcium) must be corrected before administration of Fosamax.  Patients that have suffered a non-traumatic femoral fracture (thigh bone) or osteonecrosis of the jaw should discuss discontinuation of this treatment with their health care provider.

 

If you are considering taking Fosamax, be sure your doctor checks your serum calcium levels, creatinine clearance test, screens for prior kidney disease, femur fracture and malabsorption problems.  Patients who experience esophageal problems such as difficulty or pain while swallowing and new or worsening heartburn, should reconsider taking Fosamax. All of the above are contraindicated with Fosamax.

 

Fracture Studies on Fosamax

 

In the Three-Year Fit Study fractures were reduced from 15.0% to 7.9%; and in the Four-Year Fit Study the percentages of fracture reduction went from 3.8% to 2.1%.  [1]

 

 

 

 

Emerging Safety Warnings on Fosamax and Other Bisphosphonates

  

  • Osteonecrosis of the jaw
  • Atypical subtrochanteric femoral fractures
  • Link to esophageal cancers
  • Musculoskeletal pain
  • Atrial fibrillation

Bisphosphonates include: Fosamax® (alendronate sodium), Fosamax with D®, Actonel® (risedronate sodium), Actonel with Calcium®, Atelvia® (risedronate sodium), Reclast® (zoledronic acid) and Boniva® (ibandronate sodium).

  

Osteonecrosis of the jaw is a condition that develops in the oral cavity due to the use of these drugs. "A condition that may develop in patients on bisphosphonate therapy in which pain, swelling and infection of soft tissue, drainage, loosening of teeth, and exposed bone may occur suddenly, usually at a previous tooth extraction site, as well as numbness and heaviness of the jaw." [2] Necrosis (death of the bone) occurs due to the obstruction of its blood supply.

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By Pam Flores, Health Guide— Last Modified: 12/13/11, First Published: 08/27/11