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 todetermine the exact nature of the benefits andrisks associated with taking bisphosphonates.Notably oral bisphosphonates have receivedthe most attention with intravenouspreparations also a close second.

The findings from all the research suggest thatwhile there is a clear and present risk forpatients taking bisphosphonates, the benefitscannot be ignored understated for themajority of people taking the drug that have aneed for it and for whom treatment has beentolerated well.

One of the research findings indicate that longtreatment durations are not only risky forpatients the longer they remain onprescription but also ineffectual as far asreceiving the supposed benefits of themedications are concerned.

For this reason independent medical andresearch panels as well as federal regulatorswithin the FDA have recommended thatwarning labels on treatment duration beimplemented for bisphosphonates.

However, recent reports from media sourcesindicate that the FDA has still notimplemented these warnings because theyare unable to decide on what the maximumand optimal treatment duration should be.

Some experts believe that a maximumduration of five years is enough but othersbelieve that to prevent susceptibility todeveloping complications from treatment theduration 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