A new study has confirmed a mountain of previous research identifying a link between a specific class of osteoporosis medication and an increased risk for low-trauma bone fractures, which usually involve the femur. Over the past several years, bisphosphonate osteoporosis drugs have been repeatedly linked to atypical bone fractures that often occur with little or no trauma at all. FDA-approved drugs from the bisphosphonate class include Fosamax, Actonel, Boniva, Reclast, and Zometa.
Bisphosphonate Update 6/28/12: In a new web guide published by the FDA, the administration lays out new guidance for the use of bisphosphonates, tentatively recommending a three to five year time limit for the drugs, at least until more conclusive data becomes available. The five-year time limit was originally suggested in a September 2011 report issued by the FDA, which concluded that there appears to be no tangible benefit to extending bisphosphonate regimens beyond five years. Click here to learn more.
Free Bisphosphonate Bone Fracture Lawsuit Evaluation: If you or a loved one has been injured by a bisphosphonate osteoporosis drug, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the bisphosphonate and we can help.
What’s the problem?
May 24, 2012 – In a study published this week by the Archives of Internal Medicine, Swiss researchers reached conclusions similar to those reached earlier this month by the U.S. Food & Drug Administration (FDA) – that taking osteoporosis drugs from the bisphosphonate class can increase the risk of atypical bone fractures.
The researchers analyzed data on 44 individuals ages 50 and older who experienced bone fractures between 1999 and 2010. They identified 39 patients who suffered low-trauma, atypical bone fractures, and found that all but seven of them (82%) had taken bisphosphonates for prolonged periods of time. Of the remaining 438 test subjects who experienced classic, trauma-induced femur fractures, only 6.4% had been treated with bisphosphonates. Taken cumulatively, the results of the study seem to suggest that the risk of fractures increased over time while the benefits of the drugs decreased.
Bisphosphonate drugs include:
The research included an editorial by Dr. Douglas C. Baur of the Departments of Medicine and Epidemiology and Biostatistics at the University of California, San Francisco. Dr. Baur stated that atypical bone fracture are so rare, it’s difficult to even gather enough data to study them properly.
“Atypical femur fractures are uncommon but do appear to be more frequent among individuals who are being treated with oral and intravenous bisphosphonates, and longer duration of use further increases the risk,” he said.
Baur concluded his editorial by suggesting that more in-depth research into the matter needs to be conducted, and that doctors should discontinue prescribing the drugs after three to five years in patients with a low risk of osteoporosis.
The new research comes just two weeks after the FDA published a study in the New England Journal of Medicine (NEJM) which concluded that bisphosphonates increased the risk of bone fractures in proportion to the duration of use. However, the FDA’s research was unable to determine an optimum length of time the drugs should be taken.
In October 2010, the FDA issued a press release announcing that it was requiring all manufactures of bisphosphonate drugs to update the warning labels of their products to include information about the increased risk for femur fractures. The updated warning labels urge users to consult their doctors immediately if they experience groin pain or other symptoms that may occur prior to a fracture event.
Do I Have a Bisphosphonate Bone Fracture 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 osteoporosis drug lawsuits. We are handling individual litigation nationwide and currently accepting new bone fracture cases in all 50 states.
Free Bisphosphonate Bone Fracture Lawsuit Evaluation: If you or a loved one has suffered a bone fracture you believe may have been caused by a bisphosphonate osteoporosis drug, you should contact our law firm immediately. You may be entitled to compensation by filing a bisphosphonate bone fracture suit and we can help.