American Association of Clinical Endocrinologists Responds to FDA Hearing on Bisphosphonates for Treatment of Osteoporosis

Tuesday, September 13, 2011 10:33 am EDT

Dateline:

JACKSONVILLE, Fla.

JACKSONVILLE, Fla.--(BUSINESS WIRE)--On Friday, September 9, The FDA reviewed the long term safety and efficacy of bisphosphonates, used to treat osteoporosis, which include alendronate (Fosamax), risedronate (Actonel and Atelvia), ibandronate (Boniva) and zoledronic acid (Reclast). Safety concerns discussed included esophageal cancer, osteonecrosis of the jaw or ONJ and atypical fractures of the femur. The advisory panel concluded that although atypical femur fractures and ONJ may be associated with long term bisphosphonate use, these events were seen very rarely. Although these conditions are serious, fractures which result from untreated osteoporosis are far more common therefore the benefit of taking biphosphonate seems to outweigh the risk. There is very little data linking esophageal cancer to bisphosphonate use. The panel voted 17 to 6 that labeling for these drugs should clarify the duration of use but could not agree on language for this. If implemented, this may result in the FDA limiting the duration of bisphosphonate treatment. However, the FDA is not required to follow the advice of their advisory panels; AACE therefore recommends to maintain current practice until the FDA publishes its final ruling.

The American Association of Clinical Endocrinologists urge patients who are on bisphosphonates to continue taking their medication and discuss benefits and risks of long term bisphosphonate use with their endocrinologist and/or health care professional. We believe that the 2010 AACE Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Postmenopausal Osteoporosis, will provide guidance on this decision. The guidelines can be accessed through this link.

About AACE

The American Association of Clinical Endocrinologists (AACE) represents more than 6,500 endocrinologists in the United States and abroad. AACE is the largest association of clinical endocrinologists in the world. The majority of AACE members are certified in Endocrinology and Metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. Visit our website at www.aace.com.

Contact:

American Association of Clinical Endocrinologists
Bryan Campbell, 904-353-7878
Director of Public, Media and Industry Relations
bcampbell@aace.com