FDA Acknowledges Need For Bisphosphonate Label Change

In the wake of an influx of adverse events that appear to potentially be associated with the long-term use of bisphosphonates, two advisory panels to the U.S. Food and Drug Administration (FDA) met last Friday to discuss the future labeling of certain bone-building medications. According to a 45 page Background Document issued by the FDA, the meeting was convened “to review and discuss the available data regarding the long-term (greater than 3 – 5 years) use of bisphosphonates for the treatment and/or prevention of osteoporosis.”

January 2011 witnessed the approval of a safety labeling change for bisphosphonate medications intended to treat osteoporosis. Subsequently, the following language was added to the Indications and Usage section of product labels:

Important Limitations of Use:
The safety and effectiveness of [drug] for the treatment of osteoporosis are based on clinical data of [xx] years duration. The optimal use of duration has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

However recent evidence suggest that the long term use of bisphosphonates may coincide with catastrophic complications and, therefore, warrant an updated label. Concerns over a number of long-term patients taking bisphosphonates who had suffered atypical femur fractures or osteonecrosis of the jaw (ONJ) have caused the FDA to take action. The agency has established two advisory committees to discuss, whether or not, available data is able to support the long-term use of the medications in question. Furthermore, the committees have reviewed the beneficial aspects of potentially restricting the duration of treatment and implementing a drug holiday for patients with osteoporosis who require long-term chronic therapy.

The benefits of such medications have only been seen to last for three to five years. Continued treatment beyond five years has become synonymous with severe side effects and ineffectiveness. According to the committees, studies “suggest no significant advantage of continuing drug therapy beyond five years.”

When put to a vote, 17 out of 23 panel members supported the idea of adding labels to bisphosphonate medications that “further clarify the duration of use.” Advisors who pushed for the label change believed that the side effects of long-term use were too dangerous to ignore. However, none of them acknowledged the need for stricter long-term regulations or the addition of a “black box” warning to future labels.

Proponents of the new labeling acknowledged that the new label needed to be much more specific about benefits during the first three to five years and about uncertainties after that time frame. Furthermore, a variety of factors should be considered before long-term treatment is initiated. Advisors are hoping that a more specific treatment period will significantly lower the rate of adverse events associated with the following bisphosphonates:

  • Reclast
  • Aclasta
  • Boniva
  • Fosamax
  • Didronel
  • Skelid
  • Actonel
  • Aredia
  • Bondronat
  • Zometa

Those advisors who opposed the new labeling had their own interpretations of how the situation should have been handled. Dr. Lewis S. Nelson, chairman of the FDA Drug Safety and Risk Management Committee, said the evidence warranted “something a little bit more dramatic,” like moving the statement to the “warnings” section of the label from the section on “indications and usage.”

The six people who voted against a label change said there was insufficient evidence of risk in longer use, especially with a drug proven to benefit women for the first three to five years.

Do I Have a Bisphosphonate Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in bisphosphonate lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by a bisphosphonate, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.