FDA: Anti-Osteoporosis Bisphosphonates Linked to Leg Fracture
On October 13, the Food and Drug Administration issued a warning that use of anti-osteoporosis drugs or bisphosphonates, may boost the risk of atypical thigh bone (femoral) fracture in patients on the medications.
Bisphosphonates are a class of drugs indicated to prevent and treat osteoporosis. The FDA said it is uncertain whether the elevated risk of femoral fracture was due to use of bisphosphonates.
Bisphosphonates inhibit the loss of bone mass in people with osteoporosis and use of these drugs can reduce the rate of osteoporotic fractures, the FDA said.
The agency will require a modification of the drug information on the label and in the Medication Guide to reflect the risk.
The affected drugs are those bisphosphonates indicated for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.
The warning does not affect those drugs indicated for Paget’s disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products, the FDA said.
The FDA decision, based on a review by the agency which included a report from the American Society for Bone Mineral Research Task Force, came more than half a year after the agency issued a Drug Safety Communication on March 10, 2010 to alert professionals to the risk of atypical femoral fractures associated with bisphosphonate use.
The report released on Sept 14, 2010 by the task force says "atypical femur fractures can occur anywhere in the femoral shaft, from just below the lesser trochanter to above the supracondylar flare, and are transverse or short oblique in orientation without evidence of comminution."
The FDA advised that medical professionals be aware of the risk and periodically monitor patients using bisphosphonates for more than five years; additionally, patients should continue taking bisphosphonates for osteoporosis and seek medical attention when they feel any new thigh or groin pain.
One study published in the May 3, 2007 issue of the New England Journal of Medicine found patients treated with a bisphosphonate drug were at increased risk of serious atrial fibrillation.
The bisphosphonates of concern include Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa).
A new UK case-control study reported in the British Medical Journal found that patients who took oral bisphosphonates for bone disease over five years were twice as likely to be diagnosed with esophageal cancer or cancer of the gullet.
The study was conducted by Dr. Jane Green and colleagues from the University of Oxford's Cancer Epidemiology Unit.
Another study in the Aug 2010 issue of Clinical Orthopaedics and Related Research also found use of bisphosphonates for a prolonged period may boost risk of fractures.
The study led by Isaacs J.D. and colleagues from The St George and Sutherland Hospital Orthopaedic Departments in Sidney Australia found all of 41 patients who received bisphosphonate therapy had underlying femoral insufficiency fractures while none of those 21 patients with low-energy femoral fractures prior to the anti-osteoporosis drugs becoming available had insufficiency fractures.
Dr. Joe Mercola - owner of mercola.com says in his newsletter that bisphosphonates have also been associated with serious eye inflammation and possible blindness, liver injury, ulcers, renal failure, skin reaction and hypocalcemia, in addition to atrial fibrillation, esophageal cancer and femoral fracture.
Dr. Mercola suggests the following to maintain bone health:
1) Eating large amounts of vegetables;
2) Avoiding processed foods, which lead to conditions that decrease the bone density;
3) Consuming a healthy balance between omega-6 and omega-3 fats and reduce intake of processed vegetables oils such as corn, canola, safflower, and soy oils.
4) Avoiding gluten, which is found in wheat, barley, rye, oats and spelt;
5) Avoiding soda and sugar;
6) Avoid steroids, which increase risk for osteoporosis;
7) Taking vitamin k2 supplements;
8) Taking vitamin D supplements; Vitamin D is known to benefit bone health;
10) Considering use of natural prosgesterone, which can increase bone strength.