Fosamax is an oral medication produced and marketed by Merck & Co., Inc. for the treatment of bone loss typically associated with osteoporosis and Paget’s disease. First marketed in 1994, Fosamax is the brand name for alendronate– one of several drugs classified as bisphosphonates which act to decrease cells that damage bones.
Fosamax is prescribed for the treatment of osteoporosis and other conditions associated with bone loss and the thinning of bones.
In 1995, Fosamax (alendronate) was approved by the FDA to prevent and treat the bone-thinning disorder osteoporosis.
Common side effects associated with Fosamax include stomach pain, constipation, gas, nausea, jaw pain, and heartburn. Symptoms of a serious allergic reaction include rash, itching, swelling, dizziness, trouble breathing, chest pain, and painful swallowing.
Medical studies suggest that bisphosphonate compounds like Fosamax restrict blood flow to the bone and cause Osteonecrosis of the Jaw (ONJ); a progressively debilitating condition that results in actual bone death. Also known as “Dead Jaw Syndrome,” ONJ is associated with minor jaw trauma such as tooth extractions that do not heal properly, typically leading to exposure of the bone. Serious complications often follow this exposure including extreme pain, virulent infections, tooth loss and disfigurement.
In 2004, the FDA issued a written warning to Merck about false and misleading statements about Fosamax in some of its advertising and marketing materials, and demanded removal of all misleading statements. The FDA also urged Merck to make certain Fosamax labeling changes include a warning that ONJ has been reported in patients taking bisphosphonates.
Fosamax is contraindicated in patients with abnormalities of the esophagus and other factors which delay esophageal emptying such as stricture or achalasia. The drug is further contraindicated in patients who have an inability to stand or sit upright for at least 30 minutes, and patients who experience hypersensitivity to any component of this product.
Are there patients who are more at risk for developing ONJ?
Patients most at risk for developing ONJ include those who:
- Have taken bisphosphonates
- Have taken steroids at or near the same time
- Have a previous history of cancer, osteoporosis, or Paget’s disease
- Have undergone invasive dental procedures, including extractions and/or dental implants
How can I tell if I have ONJ?
The symptoms of ONJ include:
- An irregular sore with exposed bone in either the upper or the lower jaw
- Pain in the infected jaw
- Inflammation and swelling in the infected jaw
- Loosening of teeth
- Evidence of infection, including fever and possible pus discharge
- Numbness, tingling, or other sensation changes
How long does Fosamax stay in my body?
Like other bisphosphonates, Fosamax is metabolized very slowly by the system and may remain in the body for ten years or more prolonging the risk of ONJ long after the patient stops using it.
Can I file a lawsuit if I have suffered damages from taking Fosamax?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Fosamax, you should contact your doctor immediately. You may also wish to contact an experienced Fosamax lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.