FDA Panel Recommends Stronger Warnings for Bisphosphonates

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September 12, 2011 – Last week, two FDA advisory panels recommended increasing the warnings on labels of a number of popular bisphosphonate drugs taken by millions of American women to support bone strength. Medications in the bisphosphonate class include Fosamax, Actonel and Boniva. The Defective Drug Lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits on behalf of victims injured by bisphosphonate side effects.

Bisphosphonate Bone Fracture Update 5/11/12: Researchers from the U.S. Food & Drug Administration (FDA) are expressing concern over the risk of bone fractures associated with the long-term use of a number of popular osteoporosis drugs from the bisphosphonate class. In an article published this week in the New England Journal of Medicine (NEJM), FDA researchers stated they were still uncertain as to the optimal duration for use of bisphosphonates, due to the high number of reports of atypical bone fractures in users of the drugs. Click here to learn more.

Free Bisphosphonate Lawsuit Case Evaluation: If you or a loved one has been injured by a bisphosphonate medication, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

Though the advisory panel suggested updating the warning labels of bisphosphonate medications, they failed to specify exactly what the new verbiage should state, and did not recommend limiting the use of the drugs to a proposed five years. The FDA is expected to issue the revised label in November.

According to recent estimates, more than five million women age 55 or older take bisphosphonates to prevent bone fractures in the United States alone. The bisphosphonate class of medications includes:

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

Prompted by a number of reports of atypical femur fractures and unusual jaw diseases, the two panels met jointly on September 9 to comment on the staff’s board safety review of the osteoporosis drugs. The FDA staff members stated that the benefits of bisphosphonates have only been proven for three to five years, and that the rare complications had been associated with long-term use. It has been estimated that nearly 10% of users take the drugs for longer than three years, but less than one percent take them for longer than five years.

The panel concluded with a 17-6 vote on whether the labels should ‘further clarify the duration of use’ of bisphosphonates. This wording may seem vague, but so too are the current labels, which state ‘The optimal duration of use has not been determined.’

A number of the advisors stated that the new label needed to be much more specific about the benefits of bisphosphonates up to five years, as well as the uncertainties accompanying the drugs after that. They said that patients and doctors alike should carefully weigh the risks vs. rewards of taking bisphosphonates for a prolonged period of time.

Do You Have a Bisphosphonate Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in bisphosphonate lawsuits. We are handling individual litigation nationwide and currently accepting new bisphosphonate injury cases in all 50 states.