Fosamax News: Study Links Fosamax to Atypical Femur Fractures
On September 14, 2010, a study published in the Journal of Bone and Mineral Research concluded that bisphosphonate drugs, such as Actonel, Boniva, and Fosamax, designed to build bone mass, may be related to rare but serious fractures of the thigh bone when used long term. In the most conclusive femur fracture study to date, an expert panel – comprised of doctors and scientists from the American Society of Bone and Mineral Research, the leading scientific organization on bone science – reviewed 310 cases of atypical femur fractures and found that 94% (291) of patients had taken the bone-loss drugs, most for more than five years. The femur fracture study found that these fractures occurred in the bone just below the hip. More than a quarter of the patients in the study who experienced atypical femur fractures in one leg experienced a similar fracture in the other leg.
Experts seek new warning on risk of Fosamax Fractures
The expert panel in the femur fracture study conducted a comprehensive review of both published and unpublished reports. The study’s authors also interviewed scientists at pharmaceutical companies that sell the bone-loss drugs and at the FDA, which maintains the MedWatch database that tracks the adverse effects of approved drugs. Based on the femur fracture study’s findings, the panel recommended that the FDA: (1) change the product’s labeling to alert health professionals and patients to the possibility of atypical femur fractures for patients on bisphopsphonate drugs and the warning signs of bisphopsphonate drugs, such as groin or thigh pain for a period of weeks or months before fractures; (2) develop new diagnostic and procedural codes for atypical femur fractures to improve the quality of case reporting and enable better review of medical records; and (3) establish an international registry of patients experiencing atypical femur fractures to track cases and assist with further research. The study’s co-chair, Dr. Elizabeth Shane, a professor of medicine at Columbia University, said the panel was concerned about the lack of patient awareness of atypical femur fractures and their warning signs. Millions of individuals, primarily women, have been treated with bisphosphonates such as Fosamax since they were approved in 1995. Fosamax generated $1.1 billion in sales in 2009 for New Jersey-based Merck & Co.
FDA To Continue to Evaluate Fosamax Fractures
The FDA, which was awaiting the femur fracture report before making a recommendation about bisphophonate therapy, has been given a copy of the report, and will likely make a recommendation in a few months.
Contact a Fosamax Femur Fracture Attorney
The lawyers at Bernstein Liebhard LLP are currently investigating cases concerning Fosamax fractures. If you or a loved one have fractured a femur after having taken Fosamax, you may be eligible to file a lawsuit. If you would like to discuss your legal rights, contact our attorneys today for a free and confidential case evaluation