FDA Forms Bisphosphonate Advisory Panel
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)._
For those of you who have sustained a great decrease in your quality of life due to these drugs, this is your chance to be heard We realize that many may not be able to travel to this panels location, but we hope that those who have suffered greatly and live near the committees meeting will make a concerted effort to attend to have your voices heard and to represent those who may not be able to make it due to severe disability, due to these drugs.
If you are suffering from common to severe side effects, and haven’t yet reported it please do since there is no way the FDA will know what is happening unless you make a personal report. Your doctor can make the report or you can do it your self at Adverse Events Reporting System at the FDA. The form is very easy to fill out, so don’t delay on this we need to be heard.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
FDA Advisory Committee Information Line
(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.
We hope that much can be accomplished for the patients suffering with these drugs side effects and for those not yet taking these medications. Once the long-term information is available we’ll post it here for your convenience.
Good luck to all and to those who wish to attend this meeting to have your issues and voices heard on this on-going difficult topic.
FDA Advisory Committee Calendar Joint Meeting http://www.fda.gov/AdvisoryCommittees/Calendar/ucm262477.htm
Pam wrote for HealthCentral as a patient expert for Osteoporosis.