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Sticks and Stones (and Fosamax) May Break Your Bones…

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Washington, DCA recurring theme in the Fosamax story is how a medication aimed at stemming the bone degradation that comes with osteoporosis can actually foster fractures, and specifically to the femur. Such Fosamax side effects go beyond a simple reflection of irony when three studies point to the problem as being very real, and devastating for Fosamax patients and any individual who takes bisphosphonates over the long term.

To that end, the study detailed in the British volume of the Journal of Bone & Joint Surgery (JBJS 2012 vol. 94-B no. SUPP XXXIX 189) detailed findings from 10 patients matching specific criteria attuned to the study.

According to the research, the ten female patients studied had been taking bisphosphonates, a class that includes Fosamax, for an average of 4.3 years. There were 11 fractures found amongst the group, with the fractures deemed low velocity (in other words, a fracture not stemming from exercise, task or activity, or even a fall). Still, almost half of the fractures (five out of 11) were atraumatic, and three of the fractures were bilateral subtrochanteric in nature.

Fosamax and femur fractures were also identified in a study released at the end of August, again focusing on bisphosphonates in general rather than Fosamax in particular, although as a bisphosphonate Fosamax is indeed part of the group under the microscope.

The study, published in Arthritis Research and Therapy (8/29/12), identified commonalities associated with fractures stemming from bisphosphonate use. To that end the study authors found that such fractures occurred with minimal trauma and to patients who tended to be younger than a typical patient not taking a bisphosphonate such as Fosamax, yet experiencing a similar osteoporotic fracture.

An expert panel had recommended to the US Food and Drug Administration (FDA) that the benefits of Fosamax were not verifiable beyond five years, but the agency appeared not to act on the recommendation and nowhere in the official Fosamax medication guide posted to the official FDA website is there any reference to a five-year limit on Fosamax. Some doctors have discussed the wisdom of excusing their patients from their Fosamax regimens for a time following five years of continuous use, for a so-called 'Fosamax holiday,' in an effort to minimize the risk for Fosamax and femur fractures.

It should be noted, however, that the mean timeframe for bisphosphonate use amongst the patients in the study summarized in, Seek and ye shall find - subtrochanteric stress fractures in patients on oral bisphosphonate therapy; an emerging problem, as published in JBJS was 4.3 years.

It has also been noted that any trials conducted by Fosamax manufacturer Merck & Co. prior to the approval of Fosamax did not extend beyond four years.

A patient will often file a Fosamax femur lawsuit after experiencing a low-velocity femur fracture at a relatively young age—a fracture that can affect an individual's lifestyle and in some cases livelihood.

Another grievous byproduct of bisphosphonates is Fosamax osteonecrosis of the jaw, or Fosamax ONJ. The official Fosamax prescribing information as posted on the FDA website denotes the importance of good oral hygiene and the need for regular dental care and examinations of the mouth.

The landmark Fosamax dead jaw case, Boles v. Merck & Co., Inc., 06-cv-09455 finally ended in mid-September for plaintiff Shirley Boles with a negotiated agreement for damages between Boles and Merck, in a deal reached before the case went to what would have been its third trial. Merck stressed at the time that the agreement, in the defendant's view, was not a settlement.


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