Agenda and Questions for FDA’s Meeting on Bisphosphonates

Pam Flores @phflores Health Guide
  •    Friday September 9, 2011 the Drug Safety and Risk Management Committee will meet to discuss the issues involving Bisphosphonates for the treatment and prevention of osteoporosis.


    The Food and Drug Administration released the background materials for this meeting on September 7, 2011 and the issues for committee consideration are:

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

    Included in the background materials were answers and research given by Merck-Fosamax® (alendronate sodium), Warner-Chilcott-Actonel® and Atelvia® (risedronate sodium), Novartis-Reclast® (zoledronic acid), and Roche-Boniva® (ibandronate sodium) on these two questions.

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    The answers to these questions are included in submitted literature which summarizes the clinical data findings by each company that produces drugs within this class in the links below.


    "These results suggest no significant advantage of continuing drug therapy beyond 5 years," according to agency's 45-page review of scientific evidence."


    "The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting," according to the F.D.A. report."


    We'll have to wait and see if the FDA's summary remains at the end of this scientific review.


    This committee meeting will include further discussion, before the FDA, on the two issues above, in light of "...the risk of developing osteonecrosis of the jaw, atypical fractures or esophageal cancer.  Should the committee conclude there is a risk, they will be asked to discuss if there is sufficient evidence of an optimal duration of bisphosphonates use that would minimize these risks."  In addition to the above side effects, the FDA changed the language on Reclasts' label, warning patients of possible renal failure on September 1, 2011.


    Merck's Briefing Materials


    Warner-Chilcott Briefing Document


    Novartis Briefing Document


    Roche Briefing Document


    The public will also be speaking at this meeting in the open public forum and we hope their presentations are given appropriate respect and weight.  Once the final decisions are reached, we will post the final ruling here for your prevue.


    For those who wish to attend:


    Date and Time:  September 9, 2011 from 8:00 a.m. to 4:30 p.m.


    Location:  Marriott Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd. East, Adelphi, Maryland


    Meeting Information:


    Contact Information:  FDA Advisory Committee Information Line
    1-800-741-8138 (301-443-0572 in the Washington DC area) follow the prompts to the desired center or product area.  Please call the Information Line for up-to-date information on this meeting.


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    We hope to have a decision on this in the near future after the meeting concludes on September 9, 2011.  Good luck to all who plan on attending!










Published On: September 07, 2011