Update on FDA’s Advisory Bisphosphonate Panel Meeting

Pam Flores @phflores Health Guide
  • On September 9, 2011 the Food and Drug Administration (FDA) conducted a day-long meeting of experts in the field of osteoporosis, to consider the risk and benefits of bisphosphonates.  The meeting was an assembly of medical experts, doctors, drug company's representatives and patient advocates.  During the day-long meeting we heard from a proponent of these drugs, Dr. Elisabeth Shane and Dr. Jennifer Schneider, a doctor who suffered a spontaneous femur fracture, while riding on a New York subway, and some of her support groups members who also sustained spontaneous femur fractures. Dr. Schneider started a online support, information, & advocacy group for those with this type of fracture, to help educate and provide an place for those with similar complaints with these fractures to discuss their issues.  To date, Dr. Schneider's group has approximately 120 members.

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    The risks discussed centered on femur fractures and osteonecrosis of the jaw (jaw bone death).  The benefits covered statistical information regarding the number of fractures these drugs have prevented.


    The public discussion section of the meeting had patients telling their moving accounts of numerous side effects with bone spurs, pneumonia, hospitalizations and a loss of a family member, due to renal failure/heart failure along with the patients there to represent femur fractures.  Other patients told their stories of success with these drugs and prevention of painful fractures.


    The panel was asked to answer two questions, to determine the outcome of these drugs and any possible label change to alert patients of ongoing injuries that are possible while taking bisphosphonates.


    The two FDA questions were:


    1. Does the data accumulated by the manufacturers of these drugs support long-term use of bisphosphonates for the treatment and prevention of osteoporosis?
    2. Should a drug holiday be implemented for those patients who require chronic on-going therapy of these drugs?


    In determining these answers, the panel was asked to look at the following FDA warnings that are associated with these drugs.


    Bisphosphonate side effects and FDA warnings:


    • Atrial Fibrillation
    • Osteonecrosis of the Jaw
    • Femur Fractures
    • Severe Bone and Joint Pain
    • Kidney Failure
    • Link to Esophageal Cancer

     **This is not a complete list of side effects. 


    At the end of the day a vote was taken, after hearing both sides of the arguments, and the advisory panel voted 17 to 6 to add additional warning language to all bisphosphonates package inserts, but a decision to limit the length of treatment was not reached as far as giving an exact amount of years that these drugs should be used.  The FDA does not have to follow the recommendations of these Advisory Panels, but they usually do.


    In November, we'll hear from the FDA on these two issues with a final decision which will be implemented on the Prescribing Information, and Patient Inserts of these drugs packaging and educational material. 


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    If you are a patient who's taken one of these drugs for 3-5 years, discuss with your doctor about the possibility of taking a drug holiday.  Dr. Jennifer Schneider is in favor of this type of drug treatment break, but also feels that continuing treatment may be necessary for those at high risk of fracture and who haven't been on these drugs for 5 years. 


    For anyone who's suffered a spontaneous femur fracture, while on these drugs, you may contact Dr. Schneider's support group for this, to get support, help and advice.  Dr. Schneiders' email address is publically available through various news sites, and we have permission to post it here.  To contact her send an email to: Jennifer@JenniferSchneider.com.  It is probably a good idea to include femur fracture in the subject line.


    As soon as the final report from the FDA is available we'll post it here.


Published On: September 30, 2011