Fosamax Linked to Femur Fractures
Recent data suggests a correlation between Fosamax and femur fractures. Fosamax, manufactured by Merck & Co., has been prescribed to millions of people in the United States since it was approved in 1995 for treatment of osteoporosis and Pagets disease of the bone. Although Fosamax is designed to prevent bone fractures, some studies and adverse event reports suggest that long-term use of Fosamax can actually increase the risk of fracture to the long bone.
Background:
Fosamax is in the group of medicines called bisphosphonates, which alter the cycle of bone formation and breakdown in the body. Fosamax is intended to slow bone loss while increasing bone mass, therefore preventing bone fractures. However, some reports indicate that Fosamax can harden the outer layer of bone cells, and prevent those cells from being replenished through normal bone remodeling. As a result, small fractures may accumulate and cause a spontaneous femur fracture without any immediate trauma, occurring either in the bone just below the hip joint or the long part of the thigh bone. Fosamax-related femur fractures may occur in patients engaging in low-impact activities such as walking, even though the femur is one of the strongest bones in the body.
Reported Studies and FDA Actions:
On October 13, 2010, the Food and Drug Administration revised the Warnings and Precautions label for Fosamax, and other bisphosphonates, to warn of the “risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis.” The FDA reported that symptoms often begin with dull, aching thigh pain weeks to months before a complete fracture occurs. The FDA’s report came followed a study led by the American Society for Bone and Mineral Research. In that study, 94% of the 310 individuals that sustained atypical femur fractures had taken the drug Fosamax for 5 or more years prior to their unusual fracture. In addition, another study released in the March 20, 2010 issue of the New England Journal of Medicine reported a high rate of femur fractures for women that used Fosamax long-term.
 If you or a loved one have experienced serious side effects after your use of Fosamax, it may be important to contact an attorney who can help you protect your potential legal claim. If you would like more information, or would just like to talk with a lawyer experienced in this litigation, please call us at 800-755-0098 for a free consultation or click below to fill out a free case review form. Zimmerman Reed is experienced in handling defective drug cases and we welcome any questions you may have.
|
Defective Drugs & Devices
