The FDA's updated warning, issued in January 2011, notes that bisphosphonates have been linked to atypical fractures of the femur. Although the drugs have not been proven to directly cause the fractures, the fractures are mainly reported in patients who took bisphosphonates.Based on this information, the FDA recommends that healthcare professionals periodically re-evaluate whether continued bisphosphonate therapy is needed, especially when the patient in question has been on the medication for more than five years; rule out a femoral fracture if the patient shows evidence of new thigh or groin pain; discontinue bisphosphonates if patients have evidence of femoral fracture; and discuss the benefits and risks of bisphosphonates.
Patients who experience groin or thigh pain of a dull or aching nature are encouraged to seek medical attention. Such pain can be a precursor to complete fracture and may appear months before the complete fracture occurs.
Along with Fosamax, drugs in the bisphosphonate class include Actonel (known generically as risedronate sodium), Boniva (known generically as ibandronate sodium), Atelvia (known generically as risedronate sodium) and Reclast (known generically as zoledronic acid).
READ MORE FOSAMAX LEGAL NEWS
The label on Fosamax and other bisphosphonates will be updated to reflect the new information from the FDA.
Bisphosphonates such as Fosamax have also reportedly been linked to an increased risk of osteonecrosis of the jaw, a serious condition in which the patient's jaw bone does not properly heal after minor traumas, tooth extractions or surgery, causing lost teeth and gum infections. Lawsuits have been filed against Merck, manufacturer of Fosamax, alleging the drug caused jaw bone damage.
READER COMMENTS
Kathy
on
Read the third paragraph. What do you think???
Susan
on
A year ago I fractured a bone in my hand during a fall, and it was suggested to me that I have a DEXA scan and then start using a bisphosphonate if the scan revealed osteopenia. I did neither. I had already researched the bisphosphonates after watching the Sally Field Boniva commercial in which she repeatedly states that Boniva "reverses loss". The double negative seemed odd until I found out that bisphosphonates slow bone turnover, they don't increase the growth of new bone. I wouldn't want a thick layer of dead or dying bone any more than I would want a thick layer of dead or dying skin. Dr. Schneider states "Increased bone density does not necessarily equate with good bone quality". I decided that the only purpose of the DEXA was to determine if the patient should be using a bisphosphonate. I was already using estradiol (and still am), eating well, getting regular weight-bearing exercise, and taking daily calcium and vitamin pills. The one thing I could add to my regimen wasn't a pill but extra care to avoid falls. Perhaps there's a good use of bisphosphonates, but for the average healthy 50 year old woman like myself there are other ways to combat fractures. And that's really what this is all about, minimizing fractures, not having bigger or denser bones.
I want to add that it's very odd that the FDA did a total turnaround on the femur fractures. In early 2010 they stated that there was no connection between bisphosphonate use and the fractures. Now they're admitting that there IS a connection.