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The osteoporosis drug Fosamax, which is designed to strengthen bones and reduce the risk of fractures, has been linked to osteonecrosis of the jaw, which involves deterioration and death of the jaw bone. It has also been associated with osteonecrosis of the shoulder, osteonecrosis of the knee, osteonecrosis of the hip and a possible risk of low-impact femur fractures
STATUS OF FOSAMAX LITIGATION: Several thousand Fosamax lawsuits have been filed against in Merck in recent years, alleging that the drug maker failed to provide adequate warnings about the potential side effects of the long-term use of the drug. Following Fosamax settlements and recent developments in the litigation, new cases are no longer being accepted by most product liability lawyers.
OVERVIEW: Fosamax (alendronate sodium) was approved by the FDA for the treatment of osteoporosis in October 1995. The drug is manufactured by Merck & Co., generating annual sales of over $3 billion before it became available as a generic in 2008.
Almost 20 million people have used Fosamax, which belongs to a class of drugs known as bisphosphonates. The drug works by killing osteoclast cells, which break down bone tissue. This strengthens bones and reduces the risk of long bone fractures in patients with osteoporosis.
However, Fosamax has a very long half-life, which means that it remains in the body for years. As a result, the long-term use could lead to permanent decay (osteonecrosis) of the bone in the jaw, hip, shoulder or knee as a side effect of Fosamax.
OSTEONECROSIS OF THE JAW: One of the more painful and debilitating side effects of Fosamax is osteonecrosis of the jaw, also known as ONJ or dead jaw. The link between the use of bisphosphonates and the deterioration of the jaw bone has been known for at least five years, yet Merck failed to adequately warn millions of patients about the potential side effect.
Osteonecrosis of the jaw is a rare but serious disease which can ultimately lead to surgery to permanently remove portions of the jaw. Symptoms of jaw necrosis could include pain in the jaw, swelling or infection of the gums, exposed bone inside the mouth and loose teeth or toothaches.
Individuals using Fosamax who undergo dental surgery, such as tooth extractions, are more at risk for developing osteonecrosis of the jaw. Their gums do not heal, leading to infection and exposed jaw bone.
HIP NECROSIS – SHOULDER NECROSIS – KNEE NECROSIS: On September 15, 2008, the Journal of Rheumatology released a study in which Canadian researchers evaluated osteonecrosis side effects by looking at about 88,000 health records from 1996 through 2003.
The use of bisphosphonates like Fosamax was found to increase the risk of bone necrosis nearly three times. In addition to the jaw, Fosamax side effects were linked to osteonecrosis of the shoulder, osteonecrosis of the hip and osteonecrosis of the knee. This could result in severe pain and problems with mobility.
FOSAMAX FEMUR FRACTURES: A number of individuals have reported suffering rare and unexplained femur fractures on Fosamax, which can occur after no apparent trauma.
A study published in the May/June 2008 issue of the Journal of Orthopedic Trauma found a pattern of femur fractures among Fosamax users that was 98% specific to the osteoporosis drug, involving low-energy fractures that were typically caused by falls from a standing height or less. The study also found that the average duration of Fosamax use was longer among those who had signs of these specific femur fractures than those who did not.
In addition, a Fosamax fracture case study published in September 2009, in the Journal of Bone and Mineral Research examined a patient suffering from rheumatoid arthritis with multiple risks for bone fractures who took Fosamax for eight years and developed femur fractures. The report found that the patient had an imbalance between bone resorption and bone formation at the site of a rare femur fracture known as a spontaneous bilateral subtrochanteric/diaphyseal fracture, which suggested a possible connection to the osteoporosis drug.
In 2011, new Fosamax warnings were added about the risk of atypical femur fractures.
FOSAMAX ESOPHAGEAL CANCER SIDE EFFECTS: Use of Fosamax has also been linked to an increased risk of esphageal cancer, when compared to individuals who used other bisphosphonate medications, such as Actonel or Boniva, as well as to the population at large.
According to a 2012 study presented at a meeting of the American Society of Clinical Oncology in Chicago, users of Fosamax appeared to be more than six times more likely to develop cancer of the esophagus, accounting for 96 of the 128 cases of esophagus cancer identified among adverse event reports submitted to the FDA involving individuals who developed the cancer while taking any bisphosphonate medication.