Bisphosphonates in management of osteoporosis: an FDA update


Last Friday a U.S. Food & Drug Administration (FDA) advisory committee recommended (based on a 17 to 6 vote) that the labeling of bisphosphonates needed to be updated to make it clear how long patients should take these drugs to gain the greatest benefit and suffer the least risk. Initial reports suggest that the FDA will make detailed decisions about revisions to the labeling for selected products (such as alendronate, risoderate, and zoledronic acid) before the end of this year.

In patients with osteoporosis, data suggest that there may be an increased risk for certain types of fracture and other skeletal-related events (SREs) some 3 to 5 years after the initiation of bisphosphonate therapy. However, the FDA has also made it clear that bisphosphonates have significant clinical value in the prevention of fractures and SREs in osteoporotic patients.

The “New” Prostate Cancer InfoLink wants to make it equally clear that this particular advisory committee was not being asked about the use of products like zoledronic acid (Zometa) in the management of risk of fractures in cancer patients — most specifically in the prevention of fractures among prostate cancer patients being treated with androgen deprivation therapy (ADT). The remit of the advisory committee was limited to the use of bisphosphonates in the prevention and management of osteoporesis.

At present there are insufficient data to determine whether the potential value of agents like zoledronic acid in the prevention fractures and other SREs in men on long-term ADT is time-limited, such that the risks start to outweigh the benefits over time. The fact that this appears to be the case in the management of osteoporosis suggests that it may be the case in prostate cancer patients being treated with ADT as well. However, on the basis of the currently available information, men with concerns about the long-term use of bisphosphonate therapy should absolutely not stop bisphosphonate therapy without first discussing their concerns with their doctors in as much detail as necessary.

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