This may be the first time that the Food and Drug Administration’s adverse event reporting database has been used to research the outcome of taking an osteoporosis drug, also known as bisphosphonates.
In a published study funded by the National Institutes of Health, researchers from the Feinberg School of Medicine at Northwestern University analyzed data from 1996 to 2011 from the FDA’s Adverse Event Reporting System or FAERS database.
They found as many as 26% of cases where there is a delay or a failure to heal broken bones among those taking bisphosphonates.
The drug, alendronate, was associated with 317 of those cases. Alendronate is marketed by Merck and sold as Fosamax.
The study was published in the Journal of Bone & Joint Surgery, February 20, 2013.
Dr. Beatrice Edwards and her colleagues also did a literature review from 1990 to 2012 and found 289 articles that reported an association between the drug and nonhealing femoral fractures.
Bisphosphonate use has been linked an unusual form of femur fracture known as atypical femoral fractures. These fractures can be painful and slow to heal. In 2008, the FDA required label changes on bisphosphonates and two years later warned about bisphosphonate – associated atypical femoral fractures.
Bisphosphonates such as Fosamax, Actonel, and Boniva have been linked to the death of jawbone known as osteonecrosis of the jaw (ONJ) as well as a sudden and rare fracture of the femur.
Since 2002 bisphosphonates have carried a safety warning about severe osteonecrosis of the jaw (jaw death).
The FDA took a long and hard look at the long term use of bisphosphonates and concluded most women may be able to stop taking them after three to five years, while the benefit may be residual. The use of bisphosphonates is still believed to prevent low-energy fractures among users.