Fosamax Thigh Fractures, Other Side Effects May Accompany Long-Term Use

Taking <"">Fosamax, the popular osteoporosis treatment used by millions of women, for too long may do serious damage to the bones it is supposed to protect. Debilitating Fosamax side effects may include thigh fractures, as well as a disorder called osteonecrosis of the jaw (ONJ), or dead jaw syndrome. These Fosamax side effects have prompted some medical providers to advise that women who have taken Fosamax or similar osteoporosis drugs for a while take a break from their medication.

The Fosamax thigh facture risk was confirmed last year in a study conducted by the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force. The study examined more than 300 cases involving women who had suffered subtrochanteric (just below the hip joint) or diaphyseal femur (breaks in the long part of the thigh bone) fractures. The study found that 94 percent of the patients with such fractures had taken drugs like Fosamax for osteoporosis, and most had been on the drugs for five years or more.

The Fosamax thigh fracture study prompted the U.S. Food & Drug Administration (FDA) to ask the manufacturers of Fosamax and similar osteoporosis medications to add information to the “Warnings and Precautions” section of the drugs labels’ describing the risk of atypical thigh fractures. The agency also required that a “Limitations of Use” statement be added to the “Indications and Usage” section of the labels for these drugs describing the uncertainty surrounding the optimal length of time they should be used for the treatment and/or prevention of osteoporosis. Finally, the FDA mandated that patients be given a Medication Guide that describes the symptoms of atypical femur fracture and recommends that patients notify their healthcare professional if they develop symptoms.

In 2004, researchers found a casual connection between Fosamax and ONJ, a condition in which the jawbone deteriorates due to a lack of blood supply. When a patient suffers from ONJ, the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the FDA ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ.

These potential Fosamax side effects have prompted some doctors to advice that certain of their patients go on a “drug holiday” from osteoporosis drugs like Fosamax. Some possible alternatives to Fosamax and similar osteoporosis drugs include the parathyroid hormone drug teriparatide (sold under the brand name Forteo), which works by actively building bone. A separate class of drugs called RANK ligand inhibitors, such as Prolia, that work by suppressing bone breakdown by inactivating a protein called the RANK ligand, is also an option. Selective estrogen receptor modulators also help preserve bone mass. Some of these drugs, including raloxifene and tamoxifen, are primarily used to treat breast cancer after menopause.

This entry was posted in Fosamax, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.