FDA Panels Call for Increased Warnings for Several Bone Density Drugs

During a recent meeting between the U.S. Food and Drug Administration (FDA) and two of its advisory panels, the safety of several common drugs used to treat female bone density problems was called into question. As a result, the FDA is anticipated to revise the labeling in November for medicines classified as bisphosphonates. Specific drug products include Actonel, Boniva, and Fosamax.

Women travelled from all over the country to share experiences involving injury with the FDA panels as part of the hearings on bisphosphonate dangers. Most of the stories showed similar factors, with the majority of cases involving a critical, abnormal fracture of the femur bone that occurred unexpectedly after using one of the listed bone density drugs for several years, in many instances five or more. According to statistics, over five million women and approximately 11 percent of females 55 years of age or older use these medicines to reduce bone density loss associated with pre-osteoporosis, which can also result in breaks and fractures. The current product labeling alerts users and their doctors to monitor for symptoms of pain which may be a sign of an impending fracture.

While it was concluded that heightened and clarified product warnings were necessary, it was not yet revealed what exactly that would entail. In a 45-page statement given by the FDA, the agency cited examples from data that suggest there are no documented benefits for using the drugs more than three to five years. The report also connected the problems testified by users to long term usage, which may or may not be part of the label revision.

If you or a family member has suffered an injury in Pennsylvania from using bisphosphonates (Actonel, Boniva, Fosamax) contact the Pennsylvania dangerous drug attorneys with Anapol Weiss at 1-866-735-2792 to discuss your case.

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