The Food and Drug Administration’s (FDA) bisphosphonate advisory committee held a meeting on September 9, and it resulted in a recommendation by two panels to place stronger warnings on bone-strengthening drugs such as Fosamax. There was a wide range of opinion among individual committee members, however, concerning what specific language that should be included on the revised bisphosphonate labels.
The FDA bisphosphonate advisory meeting was prompted by an increasing number of patient complaints and Fosamax lawsuits that allege bisphosphonates cause severe bone injuries such as osteonecrosis and spontaneous femur fractures. In focus at the meeting was the question of whether so-called “drug holidays” should be advised for long-term (generally considered beyond 3-5 years) bisphosphonate users.
When asked whether bisphosphonate labels should “further clarify the duration of use” the panel voted in the affirmative by a margin of 17-6. But aside from unanimity among panel members that restrictions on long-term use and an FDA black box warning were unwarranted, there was little consensus about what specific action should be taken by the FDA.
According to Dr. Lewis S. Nelson of the New York University School of Medicine, “something a little bit more dramatic” was justified by the evidence on bisphosphonates.
Tufts University School of Medicine professor Dr. Clifford J. Rosen said, “I wouldn’t put a limit of five years for therapy because that would handcuff a lot of doctors.”
Dr. John M. Kittelson of the University of Colorado Denver said he didn’t “want to cry wolf on this.”
Although not bound by the recommendations of its advisory panels, the FDA typically heeds their advice. The FDA will have the final say on the actual changes made to bisphosphonate labels, which are expected in November.
Meeting Takes Place Amidst Growing Number of Fosamax Lawsuits
The FDA meeting on bisphosphonates was held as more and more patients take legal action against Merck & Co. over the alleged side effects of Fosamax. Merck faces two federal mass torts, one of which contains claims that Fosamax causes osteonecrosis of the jaw, and the other alleging that Fosamax can lead to low-impact thigh bone breaks. Some injured Fosamax users claim that Merck knew about the health risks of long-term Fosamax use but failed to warn about them.
Injured Fosamax Users Urged to Contact RLG
For more than 25 years, the lawyers of the Rottenstein Law Group have been helping injured consumers recoup their losses caused by corporate negligence. If you suffered a femur fracture that you believe was caused by Fosamax, RLG will provide a free case review to determine whether you may be eligible to recover compensation from Merck through a Fosamax lawsuit. To begin your complimentary consultation, fill out this form or call 1-877-332-2347 .