Last week, the U.S. Food & Drug Administration (FDA) published a perspective piece on the long-term use of bisphosphonates for reducing bone fracture risk in the New England Journal of Medicine, describing findings from the agency’s September 2011 review of these drugs. The agency had reviewed data from a few studies on longer term (>3 years) use of the drugs, including whether they increased bone mineral density and decreased bone fractures.
We wrote about that review in more detail here. Essentially, the agency reported that long-term safety of these drugs was still something of a mystery, but there was concern about rare but serious complications – jaw osteonecrosis, atypical femoral fractures, and esophageal cancer. The agency has also previously stated that there was no apparent benefit of continuing the drug beyond 5 years for fracture prevention.
In the NEJM piece, agency authors reiterated both these concerns and the reality that more research and information is still needed on questions such as how long most people really should take the drugs, whether certain groups of patients are more likely to benefit from longer term use of the drugs, how long benefits of the drugs last after stopping them, and whether there are reliable measures to help make that decision in individual patients. While they don’t focus on it, there is also considerable concern and controversy about whether women who do not actually have osteoporosis (or who are classified as having “osteopenia”) should be getting these drugs in an attempt to prevent it.
The NEJM piece is likely to draw more attention to this issue than the previous FDA documents alone, and bolster advocates’ push to reconsider practices and get the information gaps filled. The National Women’s Health Network, a longtime advocate of looking closely at these issues, writes in response:
NWHN agrees with the FDA that long-term use of bisphosphonates isn’t helpful for most women, and urges women and their clinicians to seriously consider stopping these drugs after 3-5 years. Are there some women who should continue bisphosphonates beyond 3-5 years?…We will advocate for more studies to answer this important question.
Now that the FDA has acknowledged the problems of long-term use of these drugs, it should take the next step and address the important question – Which women should start taking bisphosphonates in the first place? We have urged the agency to change its recommendations to end the practice of prescribing bisphosphonates to healthy women for prevention. Too many women are handed a prescription for bisphosphonates after getting a bone density scan that shows normal age-related bone loss, even though they have no other risk factors for fracture. Those women are very unlikely to have a serious fracture in the next few years – and taking bisphosphonates isn’t likely to do them any good.
The NWHN has also recently sent a letter to FDA Commissioner Margaret Hamburg urging the agency “to remove the prevention indication for bisphosphonates and to take steps to alert women and their health care providers that these drugs are no longer recommended for prevention of osteoporosis.”