Questions about Fosamax

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What is Fosamax?

Fosamax is an oral bisphosphonate manufactured by Merck & CO., Inc, that is approved for the treatment of: osteoporosis and treatment of Paget's disease.

What are some other bisphosphonates used to treat osteoporosis?

Other common brands of bisphosphonates include: Boniva (GlaxoSmithKline), Actonel (Proctor & Gamble), and Reclast (Novartis).

What causes osteoporosis?

Typically, our bones are constantly undergoing a process of removal and rebuilding. When we are young, more is being built than removed, allowing our bones to grow and making them strong and dense, but as we age the body removes more than it builds, leading to osteoporosis (porous, brittle bones), which can affect anyone, but is most common in postmenopausal women.

How do bisphosphonates work?

Fosamax and other bisphosphonates work by inhibiting the action of special cells known as osteoclasts, which break down the bone. They do not inhibit the action of the cells that build bone, known as osteoblasts, allowing the body to maintain or increase its bone density, hopefully reducing the risk of serious fractures. However, some studies do suggest that bisphosphonates may affect the way that osteoblasts build bones.

What are the risks of using bisphosphonates?

Currently, the US Food and Drug Administration (FDA) recognizes two serious risks associated with using bisphosphonates: osteonecrosis of the jaw and potentially disabling musculoskeletal pain. A possible association with atypical thigh bone fractures has been asserted by some, but is still under investigation.

What is meant by "atypical thigh bone fractures"?

The fractures at issue is subtrochanteric or proximal diaphyseal fracture of the femur. This is a fracture in the femur (the long bone that runs from your thigh to your knee) just below the hip joint, near the junction between the ball and the shaft of the femur.

What evidence suggests an increased risk in atypical femoral fractures?

Several case reports have come forward with this type of fracture being seen in patients taking bisphosphonates. In the case reports, some doctors have suggested the connection between the drug and the injury. Two recently-presented, but not yet published, studies highlight potential risks. One study that tracked bone mineral density in 111 women, 60 of whom were taking bisphosphonates, suggested that the effectiveness of bisphosphonates decreased after four years, potentially leading to a net loss in bone mineral density. Another study looked at the bone structure of 21 people suffering atypical femoral fractures, 12 of whom were using bisphosphonates, showed that bisphosphonates decreased heterogeneity of bones, potentially leading to a degradation of bone quality.

What evidence suggests there is no increased risk of atypical femoral fractures?

One of the most commonly-cited study for saying there is no increased risk of atypical features is a cohort analysis of the Danish patient registry. The study, which included about 5200 bisphosphonate users and 11,200 controls, looked at patients over fifty years of age who had femur fractures from 1996 to 2005. The study showed that although atypical femoral fractures were more likely among bisphosphonate users, so were typical hip fractures. There was no statistically significant increase in atypical femur fractures compared to typical hip fractures, leading the study's author (who, it must be noted, does receive some funding from GSK and Novartis) to conclude that atypical femur fractures in patients taking bisphosphonates are best understood as "just part of the spectrum of fractures that you see in an osteoporotic population."

In addition, after seeing the case reports noted above, the FDA requested all data related to hip fractures from bisphosphonate manufacturers. After reviewing the data for nearly two years, the FDA concluded it "did not show an increase in [the risk of atypical femur fractures] in women using [bisphosphonates]." However, the FDA notes that its investigations are ongoing and it is not prepared to rule out the connection between bisphosphonates and atypical femur fractures.

Does it matter which bisphosphonate I take?

Because of early indications that people taking both Fosamax and Actonel experienced osteonecrosis of the jaw and musculoskeletal pain, these are considered class risks for all bisphosphonates. Because Fosamax has been around longer, and is used by more people, there is more data about the risks associated with it, but no studies have indicated that Actonel, Boniva, or Reclast have significantly reduced risk profiles for these conditions.

Can I receive compensation if I suffer one of the dangerous side effects of Fosamax or another bisphosphonate?

Drug manufacturers have a responsibility to inform doctors, patients, and others about risks associated with taking a particular drug. There is some evidence that drug manufacturers may have long known about these risks but failed to take steps to inform the FDA and warn the public. To understand the extent to which drug manufacturers may have concealed risks, it is important for men and women who suffered serious side effects to step forward with their injuries.

To learn more about your legal options, please contact the medical malpractice attorneys of Chaikin, Sherman, Cammarata, & Siegel, P.C. today for a free consultation.

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