US FDA advisors to hold September meeting on long-term safety of popular bone drugs

Two advisory committees of the US Food and Drug Administration are set to hold a public meeting on 9 September to discuss the benefits and risks of using bisphosphonate over a long term period to treat and prevent osteoporosis^1,2.

The meeting is being held in light of concerns that the long-term use of these drugs may be associated with osteonecrosis of the jaw and atypical femur fractures.

Recommendations from the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee could affect many of the estimated four million women in the US who take these drugs, notes the New York Times³.

Delegates at the meeting are expected to discuss the safety of various bisphosphonates, including among others Fosamax (alendronate sodium) tablets and solution, Actonel (risedronate sodium) tablets, Atelvia (risedronate sodium) delayed release tablets, Boniva (ibandronate sodium) tablets and injection, Reclast (zoledronic acid) injection and any generic equivalents for these products.

In October 2010, the FDA required makers of bisphosphonates to add warnings to their product labelling about the possible rare risk of femoral fracture in patients with osteoporosis taking the drug to inhibit or slow bone loss⁴.

References

1. FDA, Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement, Scheduled for 9 September 2011, www.fda.gov/AdvisoryCommittees/Calendar/ucm262477.htm

2. Federal Register, 11 July 2011, 76(132), 40753, www.gpo.gov/fdsys/pkg/FR-2011-07-11/pdf/2011-17271.pdf

3. FDA to Review Safety of Popular Bone Drugs, New York Times, 5 September 2011

4. US FDA urged to change label for bisphosophonates on link to fractures, Scrip Regulatory Affairs, 16 September 2010