FDA Panel Advises Clarified Duration for Long-Term Use of Osteoporosis Drugs
On Friday, the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 17-6 to clarify the labeling of a class of osteoporosis drugs known as bisphosphonates to better explain safety and effectiveness concerns related to long-term use. The drugs, which include popular brand-names such as Fosamax, Actonel, Boniva, and Reclast, have been under investigation in recent years due to reports of dangerous side effects.
The US Food and Drug Administration (FDA) advisory committees were asked to review data regarding the overall risks versus benefits of continuous long-term use – defined as 3 to 5 years or more. The committees were also charged with deciding whether a restriction is needed for duration of use or if implementing a “drug holiday” would be beneficial to patients.
Bisphosphonates are a class of drugs that prevent the loss of bone mass and are used to treat osteoporosis and similar diseases such as Paget’s disease. In large studies, some women taking bisphosphonates for osteoporosis have had atypical subtrochanteric and femoral fractures, jaw osteonecrosis, and increased risk for esopohageal cancer.
The overall consensus was that the use of bisphosphonates prevents fractures and reduces mortality. But for how long should they be continued, as most clinical studies have not evaluated use past 5 years?
The FDA said that more data is needed to establish long-term efficacy and safety of bisphosphonate drugs. In addition, all patients on these medications should be periodically reassessed for the necessity of continued therapy. Some research has indicated that patients who discontinued drug therapy after several years had the same fracture rates as patients who continued on the drug, suggesting there may not be a benefit to taking bisphosphonates for more than a few years.
A small study, consisting of only 32 patients, suggests that a drug holiday – where bisphosphonates are stopped for a period of time and then resumed – may possibly be beneficial, but more research is needed before issuing a recommendation.
According to the FDA, about 10 million Americans have osteoporosis and another 34 million have its precursor condition osteopenia. About seven people out of every 100 in the US received a prescription for bisphosphates in 2008. The first drug in this class of medications (Fosamax) was approved in 1995. In 2005, the FDA added a warning to the label about osteonecrosis of the jaw, a rare disease of the maxilla and mandible bones. In 2010, the label was again updated to include a warning about an increased risk for atypical femur fractures.
Regarding the possibility of an increased risk of cancer, the reviewers wrote, “No conclusion can be reached as to whether long-term use of bisphosphonates is associated with esophageal cancer (with the data currently available)."
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