The FDA last month issued an alert about the previously downplayed side-effect afflicting many bisphosphonate users of chronic, often incapacitating joint and bone pain, swelling of ankles and feet, muscles cramping, stiffness, and difficulty walking. Many users find the symptoms take a long time to subside even after stopping the drug as bisphosphonates have an indefinite half-life in the body of at least 10 years. The amount of drug within the bone accumulates with use and effect of the drug continues once stopped. There is no known method of removing the medication from the bones.[v]
There is also evidence from a large Canadian trial reported in the January 15, 2008 Journal of Rheumatology that oral bisphosphonate drugs nearly triple the risk of developing bone necrosis or bone death.[i] More…
After screening 1,825 published papers from 1966 to 2007, researchers found no evidence that bisphosphonates such as Fosamax or Actonel are superior to older bone drugs in Systematic Review: Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis. Published on-line in the January 8 2008 issue of Annals of Internal Medicine the review concluded that “data are insufficient to determine the relative efficacy or safety” of all the studied drugs.[ii]
A BMJ article, also in January 2008 warns that a series of recent scientific publications have exaggerated the benefits and underplayed the harms of osteoporosis drugs to treat pre-osteoporosis or “osteopenia” potentially encouraging treatment in millions of low risk women. [iii]
Although bisphosphonates may favourably influence bone density loss, there are concerns that because their mechanism of action suppresses the bone remodelling process, long term use may result in brittle bones that are prone to fracture. Increased bone mineralization has been shown to increase micro-fracturing in animal studies. A Connecticut woman sued Merck pharmaceuticals last week (Jan 28), claiming Fosamax has caused multiple stress fractures and suppressed bone regeneration in her legs.[iv] . JoAnn Moranski of Fairfield alleges in a complaint filed in New Jersey state court that she took the drug from 1996-2006.
According to the American Dental Association, more than 190 million prescriptions have now been written for bisphosphonates worldwide. In the light of serious emerging risks and an absence of evidence for long term safety, the current practice of widely prescribing bisphosphonates needs to be urgently reviewed. The rush to provide costly and risky medical solutions for low bone density in healthy postmenopausal women is drawing attention away from the very important issues of preventing falls in the elderly, diagnosing genuine sufferers, and encouraging regular exercise and appropriate diet to maintain bone health.
BMJ 2008; 336: 126- 129 http://www.bmj.com/cgi/content/full/336/7636/126
http://courses.washington.edu/bonephys/ opop/opdem.html
