FOSAMAX (alendronate sodium) is used to prevent and reverse bone loss, called osteoporosis, and to treat Paget's disease, a disorder marked by bone destruction and deformity. The typical patient taking FOSAMAX is a postmenopausal woman who is at risk for developing osteoporosis or who has already been diagnosed with the condition. Some men may also develop osteoporosis.
FOSAMAX belongs to a class of drugs called bisphosphonates–which also includes drugs Actonel, Boniva and Reclast, among others. FOSAMAX works by reducing bone degeneration, a process referred to as "resorption." Related to natural bone-regulating chemicals, the drug does not inhibit bone mineralization. Consequently, one can take alendronate sodium along with calcium and vitamin D supplements and see some bone mineralization. Unfortunately, the human body does not absorb the drug well, and much of it is excreted through the kidneys.
FOSAMAX, which is the brand name for alendronate, was approved by the U.S. Food and Drug Administration (FDA) in 1995 to treat postmenopausal osteoporosis and Paget's disease, which is a chronic, focal skeletal disorder characterized by greatly increased and disorderly bone remodeling. Since its approval, FOSAMAX has been taken by millions of men and women. It was first manufactured by Merck & Co., whose patent expired in 2008. It is now also manufactured by Barr Pharmaceuticals.
Harmful Side Effects Include Jaw Bone Decay and Amputation
Rather than increasing bone density and strengthening bones, in some cases FOSAMAX has actually caused a deterioration of the jaw bone or contributed to femur fractures. Despite this, neither Merck nor generic manufacturers have issued a recall on bisphosphonates.
Osteonecrosis of the Jaw
Since 2000, the FDA has known about FOSAMAX's tendency to cause osteonecrosis of the jaw (ONJ) when bisphosphonates are given to cancer patients. ONJ is a painful, disfiguring bone disease that affects people's jaw bones; specifically the bone mass in the mandible (lower jaw bone) and maxilla (upper jaw bone) die. Usually this is caused by a badly performed tooth extraction procedure that leaves a portion of jaw bone exposed. It then becomes infected and the jaw bone begins dying off. In extreme circumstances, the patient's jaw bone must be removed to prevent further bone damage. The FDA monitored ONJ and required a label change on FOSAMAX in 2005.
At present, there is no cure for ONJ, although oral rinses and antibiotics may be useful in controlling inflammation and pain (J Oral Maxillofac Surg., 2005 Nov; 63(11): 1567–75). Dentists and oral surgeons are cautious about performing tooth extractions or other dental procedures on patients taking bisphosphonates, fearing that this work could trigger jaw damage (Spec Care Dentist 2006, Jan–Feb; 26(1): 8–12).
At Long Island Jewish Medical Center in New York, Dr. Salvatore Ruggiero and other researchers reviewed the records of 63 patients with either osteoporosis or cancer who developed osteonecrosis of the jaw during the period from February 2001 through November 2003. All 63 patients had taken bisphosphonates for at least one year (J Oral Maxillofac Surg., 2004 May; 62(5): 527–34). In prior times, the medical center rarely encountered patients with ONJ, generally treating only one or two such cases per year. A review article from researchers at the Harvard School of Dental Medicine concluded that patients who receive intravenous injections of bisphosphonates increase their risk of developing ONJ by up to 10%. They were not able to calculate the exact increased risk posed by FOSAMAX and other bisphosphonates that are taken by mouth, but felt that these drugs could cause serious complications and that their use should be very carefully monitored (Ann Intern Med. 2006 May 16;144(10): 753–61). Merck's prescribing instructions for FOSAMAX did mention ONJ, but not in the prominent section entitled "Warnings." Rather, the information was buried under "Precautions."
When the jaw bones have fully decayed and died as the result of ONJ, they are impossible to fix. In extreme circumstances, the patient's jaw bone must be removed to prevent further bone damage. Prosthetic devices are implanted to provide the patient with a normally-functioning jaw.
More recently, a study conducted by the American Society for Bone and Mineral Research (ASBMR) found that FOSAMAX use correlates to sudden unusual bone fractures, particularly in the thigh bone (femur). The FDA refers to these as subtrochanteric and diaphyseal femur fractures, and on October 13, 2010, it announced that it would require a labeling change to all bisphosphonate products, including FOSAMAX. Atypical subtrochanteric femur fractures are very rare, but they appear more common among long-term FOSAMAX users. The ASBMR study investigated 310 cases of atypical femur fractures, finding that 291 of them were on bisphosphonate s. FOSAMAX users who experience any thigh pain should contact their physicians promptly.
Additional FOSAMAX Side Effects
FOSAMAX's side effects can be considerable, even after the patient stops taking the drug. This is because FOSAMAX and other bisphosphonates are incorporated into the skeleton without being degraded and persist for a long period of time. Alendronate, the main ingredient in FOSAMAX, has a half life of up to 12 years (Int J Clin Pract Suppl., 1999 Apr; 101: 18–26).
Besides increasing the risk of osteonecrosis of the jaw and femur fractures, FOSAMAX may cause severe digestive reactions, including irritation, inflammation, or ulcers of the esophagus, which is the tube connecting the throat to the stomach. Patients may also experience pain in the stomach area. Other FOSAMAX side effects include nausea, vomiting, constipation, diarrhea, gas, headaches and bone, muscle and joint pain.
Your Legal Options
Our attorneys are currently evaluating the legal claims of people who have taken FOSAMAX and developed serious jaw bone complications, osteonecrosis of the jaw, femur fractures, or other serious side effects. If you or a loved one have developed these conditions while taking FOSAMAX or after you stopped taking the drug, please contact us through this simple form or our toll–free number, 866–809–5240.