According to an FDA review of biphosphonates published on May 9, 2012 in the New England Journal of Medicine, long term use of these drugs, commonly known as Boniva or Fosamax, could lead to weakened bones. In these cases, women suffered Fosamax side effects including serious and unusual femur fractures and osteonecrosis of the jawbones.
The FDA now questions whether there are any benefits to use outside of a 3 to 5 year window. The FDA does not suggest that they would not be helpful to people with very low bone density but brings up concerns of long-term use that would outweigh long term benefits. The FDA does not recommend heightened warnings but does suggest that women with moderate bone density depletion should stop use after 3 to 5 years on the drugs.
Research concluded that those likely to benefit from long term use are only those who even after years of therapy continue to have very low bone density. Researchers also suggested that 60 to 70 percent of users would be candidates for stopping use after 3 to 5 years. These research findings come from a study lead by the University of California, San Francisco.
Over a 10-year period, Fosamax was studied and according to the FDA review, there were no long-term benefits from long-term use. They also studied Reclast, an injectable drug, for 6 years and had very similar conclusions. Although these serious complications are not extremely prevalent the risk does not outweigh the benefits of long-term use of the drug for most users.
- Concerns raised over long-term use of bone drugs (mercurynews.com)
- Well: New Cautions About Bisphosphonates (well.blogs.nytimes.com)
- FDA Still Cautious About Bone Drugs – ABC News (abcnews.go.com)
- Fosamax Femur Fractures and Osteonecrosis of the Jaw to be Reviewed by FDA in September (prweb.com)
- Think About Your Bones When You Take Fosamax (fosamaxbonefractures.typepad.com)
- US Drug Watchdog and Fosamax (fosamaxfracturelawsuit.typepad.com)
- US Drug Watchdog Now Urges All Women Who Have Had A Femur Or Thighbone Fracture To Call Them If The Injury Occurred While Using The Osteoporosis Drug Called Fosamax (prweb.com)
- The Unwanted Side Effects of Fosamax (fosamaxfracturelawsuit.typepad.com)
- US Drug Watchdog Calls For Increased National Awareness Of Osteoporosis Drugs Such As Fosamax & Women Who Have Had A Unexplainable Femur Fracture (prweb.com)
- Rottenstein Law Group Notes Report Suggesting Bone Density Retesting Can Be Postponed (prweb.com)