Dr. Elizabeth Shane will speak before the FDA tomorrow to discuss the risk and benefits of long-term use of bisphosphonates, in light of recent developments of osteonecrosis of the jaw (jaw bone death), renal failure warnings and atypical femur fractures.
Dr. Shane is the past-president of the American Society for Bone and Mineral Research (ASBMR) and an endocrinologist and professor of Medicine at Columbia University in New York, with more than 25 years of experience caring for patients with osteoporosis. Additionally she served as co-chair of two ASBMR scientific task forces on bisphosphonate use.
The public is invited to attend this meeting, and some patients where chosen to speak, prior to August 18, 2011, during the public forum section between 1:00 p.m. and 2:00 p.m. If you'd like to attend this meeting, see the information on the FDA's joint committee meeting.
The FDA has asked the manufacturers of the osteoporosis drugs to submit scientific analysis on the long-term risk and benefits of these drugs, and whether or not a drug holiday for patients taking these would be a prudent course of action.
The drugs in question are: Actonel, Atelvia, Reclast, Boniva intravenous and oral, and Fosamax, plus its generic forms.
The drug companies have submitted pre-meeting materials in response to the FDA's questions about these drugs, released yesterday, September 7, 2011.
The inclusion of Dr. Elizabeth Shane is a welcome surprise, as she has completed many studies on the occurrences of atypical femur fractures, and has been very vocal about this development within the use of this class of drugs.
In the pre-meeting notes, it states that Dr. Shane will testify that bisphosphonates are very important drugs for prevention of fractures due to osteoporosis. While bisphosphonates are associated with ONJ and atypical femur fractures, the absolute risk of both conditions is very low, particularly when compared to the number of extremely common fractures prevented by these drugs.
Shane will also push for new diagnostic and procedural codes should be developed for atypical femur fractures, as has already been accomplished for ONJ, to improve the quality of case reporting and enable better review of medical records.
Also to be recommended is an international registry of patients experiencing atypical femur fractures should be established to track cases and facilitate future research.
One of the main problems with tracking these fractures is the problem of diagnostically coding them at the emergency rooms, where these types of injuries may initially look like typical fractures from trauma seen often with osteoporosis. If the hospitals mistakenly report these fractures with osteoporotic causes, then these atypical fractures won't be registered and coded properly. Due to this, we don't have a true figure of how many of these non-traumatic fractures have actually occurred. With the inclusion of Dr. Shane's international registry, to track these cases and have them coded properly, hopefully we'll finally have a true figure of how many of these occurred world wide.