Independent Advocates Urge FDA to Enforce Changes to Bisphosphonate Drug Labels
Plaintiffs claiming injury and compensation
Independent panels from the American Society for Bone Mineral Research and the Journal of Bone and Mineral Research have petitioned the FDA to take a stronger stance on changing warning labels on bisphosphonate medications, medical experts say, in relation to their accepted treatment durations. With the mounting evidence supporting legal claims of bisphosphonate related complications, many advocate and research groups are urging the FDA to issue stronger warning measures of the dangers and recent findings for these types of medications. The distinct lack or incomplete warning labels has been one the main points of contention in legal battles between plaintiffs claiming injury and compensation against drug manufacturers.
A great body of research has been done to determine the exact nature of the benefits and risks associated with taking bisphosphonates. Notably oral bisphosphonates have received the most attention with intravenous preparations also a close second. The findings from all the research suggest that while there is a clear and present risk for patients taking bisphosphonates, the benefits cannot be ignored understated for the majority of people taking the drug that have a need for it and for whom treatment has been tolerated well.
One of the research findings indicate that long treatment durations are not only risky for patients the longer they remain on prescription but also ineffectual as far as receiving the supposed benefits of the medications are concerned. For this reason independent medical and research panels as well as federal regulators within the FDA have recommended that warning labels on treatment duration be implemented for bisphosphonates.
However, recent reports from media sources indicate that the FDA has still not implemented these warnings because they are unable to decide on what the maximum and optimal treatment duration should be. Some experts believe that a maximum duration of five years is enough but others believe that to prevent susceptibility to developing complications from treatment the duration should be shortened even further.
What is clear to all experts is that osteoporosis is a chronic disease condition that occurs differently at different times for different people and treatment regimens should be guided accordingly to prevent unnecessary abuse and development of complications. While many still feel that the warnings should be implemented by the manufacturer’s and enforced by federal authorities, the current law doesn’t support this action and thus the debate is still ongoing.
For more information and updates on bisphosphonate side-effects and controversies surrounding them, visit Fosamax Class Action Lawsuit blog for more details.
URL References:
A great body of research has been done to determine the exact nature of the benefits and risks associated with taking bisphosphonates. Notably oral bisphosphonates have received the most attention with intravenous preparations also a close second. The findings from all the research suggest that while there is a clear and present risk for patients taking bisphosphonates, the benefits cannot be ignored understated for the majority of people taking the drug that have a need for it and for whom treatment has been tolerated well.
One of the research findings indicate that long treatment durations are not only risky for patients the longer they remain on prescription but also ineffectual as far as receiving the supposed benefits of the medications are concerned. For this reason independent medical and research panels as well as federal regulators within the FDA have recommended that warning labels on treatment duration be implemented for bisphosphonates.
However, recent reports from media sources indicate that the FDA has still not implemented these warnings because they are unable to decide on what the maximum and optimal treatment duration should be. Some experts believe that a maximum duration of five years is enough but others believe that to prevent susceptibility to developing complications from treatment the duration should be shortened even further.
What is clear to all experts is that osteoporosis is a chronic disease condition that occurs differently at different times for different people and treatment regimens should be guided accordingly to prevent unnecessary abuse and development of complications. While many still feel that the warnings should be implemented by the manufacturer’s and enforced by federal authorities, the current law doesn’t support this action and thus the debate is still ongoing.
For more information and updates on bisphosphonate side-effects and controversies surrounding them, visit Fosamax Class Action Lawsuit blog for more details.
URL References:
- verusmed.com/articles/view/67414/
- community.breastcancer.org/forum/73/topic/774656