Reno, NVPatients who were diagnosed with osteopenia and prescribed Fosamax could be forgiven for thinking that the Fosamax side effects might be more trouble than the condition the drug was treating. Lawsuits filed against the maker of Fosamax suggest patients were not adequately warned about the link between Fosamax and femur fractures, or Fosamax osteonecrosis, with some patients saying they suffered a Fosamax femur fracture after taking the drug for a relatively mild condition.
Osteopenia is a fairly minor condition in which the patient's bone mineral density is lower than ideal, but not low enough for an osteoporosis diagnosis. Patients with osteopenia have bones that are weaker than normal, but not so weak as to be a serious health risk. There is a greater chance of patients with osteopenia developing osteoporosis than patients without osteopenia, but bone thinning is also a natural part of aging. Furthermore, not everyone with osteopenia has bone loss. For example, some people naturally have thinner bones than others.
Fosamax (known generically as alendronate) is prescribed to increase bone density in patients who have osteoporosis. It is often prescribed, however, in patients with osteopenia to prevent osteoporosis from developing. What that means for patients, is that they are put at risk of Fosamax side effects when in reality they are treating a minor condition.
Reportedly among the more serious of the Fosamax side effects is the risk of atypical femur fracture, a serious fracture of the femur, often brought about by non-traumatic actions, such as normal walking (in other words, there was no traumatic action, such as a car accident, that caused the fracture). Because Fosamax is used to treat a condition that can be ongoing, many patients take it for long periods, not realizing that increased length of time on the drug, and increased dose, could further heighten the risk of side effects.
On June 27, 2012, the US Food and Drug Administration (FDA) issued an update that some patients could be good candidates to discontinue taking bisphosphonates (the class of drug that Fosamax belongs to, which also includes Actonel, Atelvia and Boniva) after three to five years.
On October 13, 2010, the FDA issued a warning that bisphosphonates were potentially linked to an increased risk of atypical femur fractures and announced that drugs in the class would undergo a label change to reflect this risk. The agency noted that many patients reported pain in the femur area in the weeks and months leading up to the fracture.
Lawsuits have been filed against Merck, maker of Fosamax. So far, of the bellwether trials to go to court alleging Fosamax is linked to osteonecrosis of the jaw, Merck has won all but one lawsuit.
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