For many years we've heard about the numerous serious side effects from the osteoporosis medications, namely bisphosphonates that include Fosamax, Boniva (oral and IV) Reclast, Actonel and Atelvia.  These side effects range from minor to severe gastrointestinal disorders, like GERD, espohagitis, stomach disorders/ulcers, bone and joint pain and swallowing problems, to the severe side effects like esophageal cancer, low-trauma femur fractures, BIONJ (bisphosphonate-induced osteonecrosis of the jaw - dead jaw bone) atrial fibrillation and renal failure among others.  Along with all these side effects has come reports from doctors and patients to the FDA's Adverse Events Reporting System.  As a result of all these medical complaints the FDA added additional warning information on the package insert of these drugs several years ago, but now we have long-term evidence that can be evaluated since one of these drugs has been on the market for 16 years (Fosamax) and the others range from 10 to 1 years of patient use.

The Drug Safety and Risk Management Advisory Panel will be held on September 9, 2011 at the Marriott Inn and Conference Center in Adelphi, MD.  The public is encouraged to attend these proceedings, and if you have a complaint with one of these drugs or sustained serious side effects, they want to hear from you.  For more information on this meeting contact Kalyani Bhatt at the Center for Drug Evaluation and Research at ACRHD@fda.hhs.gov.   For more information on the meeting agenda, go to FDA.gov the FDA will start this new advisory panel on bisphosphonates which will hopefully supply more concrete information on these side effects and what actions can be taken to minimize them.  Usually these advisory panels are convened to prompt a change or additional warning on the package insert, or a recall.  By law the FDA does not have to follow the committees' suggestions, but usually they do.

If you're planning on attending you may present your information in written submission or formal oral presentation form. 

Public Participation Information:

Interested persons may present data, information or views, orally or in writing, on issues pending before the committee.

• Written submissions may be made to the contact person on or before August 25, 2011.
• Oral presentation from the public will be scheduled between approximately 1pm-2pm, September 9, 2011.  Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 17, 2011.

 If you require special accommodations, for the meeting, due to a disability, please contact Kalyani Bhatt at (301) 796-9001 at least 7 days in advance of the meeting (more information below).