The U.S. Food & Drug Administration (FDA) is suggesting that osteoporosis patients limit their use of a popular line of drugs which includes Fosamax, Actonel and Boniva to between three and five years in order to reduce the risk of serious side effects. These medications belong to a controversial class of drugs known as bisphosphonates, which are designed to reduce the risk of bone fractures associated with the onset of osteoporosis. However, in recent years concerns have emerged linking bisphosphonates to serious atypical bone fractures, which often occur with little or no trauma at all.
Free Bisphosphonate Lawsuit Evaluation: If you or a loved one has been injured by a bisphosphonate 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?
June 28, 2012 – 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. That report was submitted before an independent advisory committee to the administration met to assess the risks involved with long-term use of the drugs. Before the committee adjourned, the members voted to place enhanced bone fracture warnings on the labels of bisphosphonate medications, but they failed to finalize any definitive length-of-use recommendations.
“These drugs clearly work,” said Dr. Marcea Whitaker, an FDA medical officer and co-author of a study on Fosamax recently published in the New England Journal of Medicine (NEJM). “We just don’t know yet the optimum period of time individual patients should be on the drug to both maximize its effectiveness and minimize potential risks.”
In October 2010, the FDA issued a press release announcing that it was requiring updated warnings about the risk of atypical thigh fractures from bisphosphonate osteoporosis drugs. During an analysis of the potential side effects of the medications, the administration determined that the increased fracture risk seemed to be associated with the long-term use of bisphosphonates.
Pharmaceutical giant Merck & Co. is currently facing hundreds of Fosamax lawsuits filed in courthouses around the country on behalf of individuals who claim the company failed to adequately warn the public about the potential health risks linked to the medication. The complaints allege that Fosamax has the potential to weaken the femur bone’s ability to repair itself from microdamage, thus increasing the risk of unanticipated low-impact fractures.
Do I 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 side effects cases in all 50 states.
Free Bisphosphonate Lawsuit Evaluation: If you or a loved one has been injured by a bisphosphonate drug, you should contact our law firm immediately. You may be entitled to compensation by filing a bisphosphonate injury suit and we can help.