The FDA is giving women a lot to chew on with a new analysis of long-term use of drugs for osteoporosis because they can, although rarely, have a debilitating effect.
The review was published Wednesday online in The New England Journal of Medicine, reports The New York Times. The review says there is limited, if any, benefit from the drugs after three to 5 years of use.
The drugs are taken by millions of women who have come to believe that they are their best defense against bone loss. And, of course, the pharmaceutical industry has come to believe that women will continue to buy large quantities of the drugs. So, if the pattern changes, it could have implications for drugs like Fosamax from Merck ($MRK) and Roche's ($RHHBY) Boniva, as well as for some genericsmakers. It also may create a moment of reflection for those companies still developing osteoporosis treatments.
The agency in March said that it requested data from drugmakers in 2008 after reports of femur fractures in women using bisphosphonates. The drugs have been linked to osteonecrosis of the jaw (Merck is fighting lawsuits over Fosamax's association with the bone-death syndrome) and severe musculoskeletal pain. In addition, the FDA also looked at a potential association with femur fractures.
The review does not address whether women at risk should be prescribed the drugs in the first place, and because the repercussions from long-term uses are so rare, many doctors believe that the benefits for women at high risk for spinal fractures far outweigh the risks.
But for women with only marginal risk, the review may serve as a turning point in popular practice.
"I think a lot of people are going to come off this drug," Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute, told The Times.
- see The New York Times piece
Related Articles:
FDA reviewing bone meds' fracture risk
VCs rally behind Tarsa Therapeutics in $28M B round