- Thu, 04/05/2012 - 9:17am
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On December 19th 2011, Health Canada officials issued a warning against use of bisphosphonate drugs including Fosamax®, Actonel®, and other similar bone strengthening medications. It was found during a safety review that these drugs pose an increased risk for developing atypical femur fractures.
As a result, new warning labels will be issued in order to reflect this increased risk of bone fractures. Atypical thigh bone fractures occur in less than one percent of all hip and femur fractures, however, Health Canada has determined that bisphosphonates double that risk.
In the U.S., a panel of FDA advisors met to discuss Fosamax femur fracture side effects and voted that more informational warning labels needed to be issued. The FDA is not required to follow these recommendations, although they typically do. No word has been released regarding the decision of the FDA to mandate more informational warning labels.
On January 7 of 2008, the Food and Drug Administration (FDA) issued a medical advisory warning doctors and patients about the side effects of bisphosphonate use. Researchers who have studied bisphosphonates drugs say that Fosamax is shown to slow down the rate at which the human body replaces old bones with new, causing micro fractures to eventually become major fractures. This process, known as bone turnover suppression, is what causes the femur to fracture.
In October of 2010, stronger warning labels were mandated by the FDA regarding the risk for thigh fractures from use of Fosamax and other bisphosphonate drugs.
Those who have taken Fosamax continue to pursue compensation by filing Fosamax lawsuits against Merck & Co., the manufacturer of Fosamax. Victims accuse the drug manufacturer of failing to properly warn about the risks associated with long term use of Fosamax. Merck counters these accusations by stating that no results of the side effects were discovered in their clinical trials prior to releasing Fosamax.